Regaine Extra Strength 5% w/v Cutaneous Solution

  • Name:

    Regaine Extra Strength 5% w/v Cutaneous Solution

  • Company:
    info
  • Active Ingredients:

    Minoxidil

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/12/16

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Summary of Product Characteristics last updated on medicines.ie: 13/11/2019

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McNeil Healthcare (Ireland) Ltd

McNeil Healthcare (Ireland) Ltd

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Medicine Name Motilium 1mg/ml Oral Suspension Active Ingredients Domperidone
Medicine Name Motilium Rx 10 mg Film-coated Tablets Active Ingredients Domperidone
Medicine Name Regaine Extra Strength 5% w/v Cutaneous Solution Active Ingredients Minoxidil
Medicine Name Vermox 100mg/5ml Oral Suspension Active Ingredients Mebendazole
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 13 November 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 4 October 2019 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

Legal category: Supply through pharmacy only

Updated on 4 October 2019 SmPC

Reasons for updating

  • Previous version of SmPC reinstated

Legal category: Supply through pharmacy only

Updated on 18 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Supply through pharmacy only

Updated on 8 December 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 8 December 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

"Allergic reactions including angiodema" was added to the table in Section 4.8 Undesirable Effects. The date in section 10 was also updated to reflect the approval date.

Updated on 8 December 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 December 2016 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 8 July 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

PRESENT

PROPOSED

SPC

 

.2         Posology and Method of Administration

 

Adults between 18 and 65 years of age:

 

Hair and scalp should be thoroughly dry prior to topical application of Regaine Extra Strength. A dose of 1 ml Regaine Extra Strength should be applied to the total affected areas of the scalp twice daily.  The total dosage should not exceed 2 ml.  If fingertips are used to facilitate drug application, hands should be washed afterwards.

 

Clinical experience indicates that twice daily applications for six weeks may be required before evidence of a reduction in hair-loss can be seen and for two months or more before evidence of hair growth can be expected. Onset and degree of hair growth may be variable among patients.

 

Continuous twice-daily usage is necessary to maintain the results of treatment.

Relapse to pre-treatment appearance following discontinuation of medication has been reported to occur within 3-4 months.

 

In the absence of any clear response in men, the treatment should be discontinued after 12 months (8 months in women).

 

The method of application varies according to the disposable applicator used:

 

Pump spray applicator:  this is useful for large areas.  Aim the pump at the centre of the bald area, press once and spread with fingertips over the entire bald area.  Repeat for a total of 6 times to apply a dose of 1 ml.  Avoid breathing spray mist.

 

Extended spray tip applicator:  this is useful for small areas, or under hair.  The pump spray applicator must be in place in order to use this additional applicator.  Use in the same way as the pump spray.

 

The solution is flammable and exposure of the container and contents to naked flames should be avoided during use, storage and disposal.

.2         Posology and Method of Administration

 

Posology

 

Adults men and women between 18 and 65 years of age:

 

Hair and scalp should be thoroughly dry prior to topical application of Regaine Extra Strength. A dose of 1 ml Regaine Extra Strength should be applied to the total affected areas of the scalp twice daily (once in the morning and once in the evening).  The total dosage should not exceed 2 ml.  If fingertips are used to facilitate drug application, hands should be washed afterwards.

 

It may take at least 2 to 4 months of twice a day treatment before results are seen. Clinical experience indicates that twice daily applications for six weeks may be required before evidence of a reduction in hair-loss can be seen and for two months or more before evidence of hair growth can be expected. Onset and degree of hair growth may be variable among patients.

 

Continuous twice-daily usage is necessary to maintain the results of treatment.

Relapse to pre-treatment appearance following discontinuation of medication has been reported to occur within 3-4 months.

 

In the absence of any clear response in men, the treatment should be discontinued after 12 months (8 months in women).

 

The method of application varies according to the disposable applicator used:

 

Pump spray applicator:  this is useful for large areas.  Aim the pump at the centre of the bald area, press once and spread with fingertips over the entire bald area.  Repeat for a total of 6 times to apply a dose of 1 ml.  Avoid breathing spray mist.

 

Extended spray tip applicator:  this is useful for small areas, or under hair.  The pump spray applicator must be in place in order to use this additional applicator.  Use in the same way as the pump spray.

 

The solution is flammable and exposure of the container and contents to naked flames should be avoided during use, storage and disposal.

 

Method of administration

 

For topical use only.

 

The hair and scalp should be thoroughly dry prior to topical application.

 

Wash hands thoroughly after application.

 

Special populations

 

There are no specific recommendations for use in elderly patients or in patients with renal or hepatic impairment.

 

Pediatric population

 

Regaine is not recommended for use in children below the age of 18 years due to lack of data on safety and efficacy.

 

4.4       Special Warnings and Special Precautions for Use

 

The safety and efficacy of the product in patients aged fewer than 18 or over 65 is unknown.

 

Minoxidil should only be used on a normal healthy scalp. Do not use if scalp is red, inflamed, infected or painful or if using other medications on the scalp.

 

Minoxidil is only indicated for the treatment of alopecia androgenetica and should not be used in other types of hair loss for example when there is no family history of hair loss, hair loss is sudden and/or patchy, hair loss is due to childbirth or the reason for hair loss is unknown.

 

The patient should stop using Regaine Extra Strength and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart-beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp.

 

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine Extra Strength.

 

Accidental ingestion may cause serious cardiac adverse events.  Therefore this product has to be kept out of the reach of children.

 

Regaine Extra Strength is for external use only.  Do not apply to areas of the body other than the scalp.

 

Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should be avoided.

Regaine Extra Strength Topical Solution contains ethanol (alcohol), which will cause burning and irritation of the eye.  In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water. Propylene Glycol, contained in this product, may cause skin irritation.

 

Some patients have experienced changes in hair colour and/or texture with Regaine use.

 

Some consumers reported increased hair shedding upon initiation of therapy with Regaine Extra Strength. This is most likely due to minoxidil’s action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Regaine Extra Strength and consult their doctor.

 

Users should be aware that, whilst extensive use of Regaine Extra Strength has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.

 

4.4       Special Warnings and Special Precautions for Use

 

The safety and efficacy of the product in patients aged fewer than 18 or over 65 is unknown.

 

Minoxidil Regaine should only be used on a normal healthy scalp. Do not use if scalp is red, inflamed, infected, irritated or painful. or if using other medications on the scalp.

 

Regaine should not be used concurrently with any other medicines on the scalp

 

Minoxidil Regaine is only indicated for the treatment of alopecia androgenetica and should not be used in other types of hair loss for example when there is no family history of hair loss, hair loss is sudden and/or patchy, hair loss is due to childbirth or the reason for hair loss is unknown.

 

The patient should stop using Regaine Extra Strength and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart-beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp, or other unexpected new symptoms occur (see section 4.8)..

 

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine Extra Strength.

 

Accidental ingestion may cause serious cardiac adverse events.  Therefore this product has to be kept out of the reach of children.

 

Regaine Extra Strength is for external use only.  Do not apply to areas of the body other than the scalp.

 

Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should be avoided.

 

Regaine Extra Strength Topical Solution contains ethanol (alcohol), which will may cause burning and/or irritation of the eye.  In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water. Propylene Glycol, contained in this product, may cause skin irritation.

 

Some patients have experienced changes in hair colour and/or texture with Regaine use.

 

Some consumers reported increased hair shedding upon initiation of therapy with Regaine Extra Strength. This is most likely due to minoxidil’s action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Regaine Extra Strength and consult their doctor.

 

Users should be aware that, whilst extensive use of Regaine Extra Strength has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (e.g. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.

 

Using more than the recommended dose or applying more often will not improve results.

 

Continued use is necessary to increase and maintain hair re-growth, or hair loss will begin again.

 

Unwanted hair growth may be caused by the transfer of the product to areas other than the scalp.

 

4.5       Interactions

 

Pharmacokinetic drug interaction studies in humans revealed percutaneous minoxidil absorption is enhanced by tretinoin and anthralin as a result of increased stratum corneum permeability; betmethasone dipropionate increases local tissue concentrations of minoxidil and decreases systemic minoxidil absorption.

4.5       Interactions

 

Topical minoxidil should not be used concurrently with any other medications on the scalp.

 

Pharmacokinetic drug interaction studies in humans revealed percutaneous minoxidil absorption is enhanced by tretinoin and anthralin as a result of increased stratum corneum permeability; betmethasone dipropionate increases local tissue concentrations of minoxidil and decreases systemic minoxidil absorption.

 

Guanethidine has been reported to interact with oral formulations of minoxidil resulting in rapid and pronounced lowering of blood pressure

 

4.6       Pregnancy and Lactation

 

Systemically absorbed minoxidil is secreted in human milk.

There are no adequate and well controlled studies in pregnant women. Animal studies have shown a risk to the fetus at exposure levels that are very high compared to those intended for human exposure. A low, albeit remote, risk of fetal harm is possible in humans.

 

Topical minoxidil should only be used during pregnancy or lactation if the benefit to the mother outweighs the potential risk to the fetus or nursing infant.

 

4.6       Fertility, Pregnancy and Lactation

 

Systemically absorbed minoxidil is secreted in human milk.

Topical minoxidil should not be used during pregnancy and lactation.

 

Fertility

 

There are no adequate and well controlled studies relating to female fertility.

 

Studies in animals have shown fertility toxicity - reduced conception and implantation rates as well as a reduction in the number of live pups at exposure levels that are very high compared to those intended for human exposure (see section 5.3). The potential risk in humans is unknown.

 

Pregnancy

There are no adequate and well controlled studies in pregnant women. Animal studies have shown a risk to the foetus at exposure levels that are very high compared to those intended for human exposure. There is potentially a risk of foetal harm in humans (see section 5.3, Preclinical safety data).A low, albeit remote, risk of fetal harm is possible in humans.

 

Breastfeeding

 

Systemically absorbed minoxidil is secreted in human milk. The effect of minoxidil on newborns/infants is unknown.

 

 

Topical minoxidil should only be used during pregnancy or lactation if the benefit to the mother outweighs the potential risk to the fetus or nursing infant.

 

4.7       Effects on ability to Drive and Use Machines

 

Based on the pharmacodynamic and overall safety profile of topical minoxidil, it is not expected that Regaine Extra Strength would interfere with the ability to drive or operate machinery.

 

4.7       Effects on ability to Drive and Use Machines

 

Minoxidil may cause dizziness or hypotension. If patients are affected they should not drive or operate machinery.Based on the pharmacodynamic and overall safety profile of topical minoxidil, it is not expected that Regaine Extra Strength would interfere with the ability to drive or operate machinery.

 

4.8       Undesirable Effects

 

In placebo controlled trials, the overall frequency of adverse events in females in all body system categories was approximately five times that of males.

 

Several thousand patients have used topical minoxidil in clinical trials where a comparison with an inactive solution was made.  Dermatological reactions (e.g. irritation, itching) occurred in patients using both solutions. This has been explained by the presence of propylene glycol in both the active and inactive solution.

 

Data from 7 placebo controlled trials are available with a population of 1,197 males and females treated with topical minoxidil solution (2% and 5% combined) where adverse events were assessed. Additionally, adverse events reported in post-marketing are included.

 

The frequency of adverse reactions to topical minoxidil solution is defined using the following convention:

Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

 

The following adverse events were associated with placebo controlled clinical trials:

 

Body system

Incidence

Reported adverse event

Nervous system disorders

Very common:

Headache

Vascular disorders

 Common:

 

Hypertension*

 

Respiratory, thoracic and mediastinal disorders

Common:

Dyspnoea

Skin and subcutaneous tissue disorders

Common:

 

 

 

 

 

Hypertrichosis (unwanted non-scalp hair including facial hair growth in women), pruritus, rash, (including rash pruritic and application site, pustular, papular, generalized vestibular and macular rash), eye pruritus acneform, dermatitis (including contact, application site, allergic, atopic and seborrhoeic dermatitis) and inflammatory skin disorder.

 

General disorders and administration site conditions

Common:

 

 

 

Oedema peripheral

 

 

Psychiatric disorders

Common:

Depression

 

Muscoskeletal

Common

Muscoskeletal pain

Miscellaneous

Common:

Pain

* This adverse event was identified during a clinical trial for Minoxidil Foam

The following adverse events were associated with post marketing experience:

 

Body system

Incidence

Reported adverse event

Nervous system disorders

Rare

Headache

Vascular disorders

Uncommon

 

Hypotension

 

Cardiovascular disorders

Rare:

Palpitations

Increased heart rate

Chest pain

 

Skin and subcutaneous tissue disorders

Uncommon:

 

 

 

 

 

Hypertrichosis (unwanted non-scalp hair including facial hair growth in women), temporary hair loss, changes in hair texture and hair colour, skin exfoliation, dry skin and rash.

Rare

Contact dermatitis

General disorders and administration site conditions

Uncommon:

 

 

Rare

Application site irritation and application site pruritis

 

Application site erythema.

 

 

 

 

4.8       Undesirable Effects

 

In placebo controlled trials, the overall frequency of adverse events in females in all body system categories was approximately five times that of males.

 

Several thousand patients have used topical minoxidil in clinical trials where a comparison with an inactive solution was made.  Dermatological reactions (e.g. irritation, itching) occurred in patients using both solutions. This has been explained by the presence of propylene glycol in both the active and inactive solution.

 

The safety of topical minoxidil from clinical trial data is based on data from 7 placebo-controlled randomised clinical trials in adults evaluating either 2% or 5% minoxidil solution, and two placebo-controlled randomised clinical trials in adults evaluating a 5% foam formulation.

 

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with minoxidil are included in the table below by System Organ Class (SOC).

 

Data from 7 placebo controlled trials are available with a population of 1,197 males and females treated with topical minoxidil solution (2% and 5% combined) where adverse events were assessed. Additionally, adverse events reported in post-marketing are included.

 

The frequenciesy of adverse reactions to topical minoxidil solution is defined usingare provided according to  the following convention:

Very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

 

The following adverse events were associated with placebo controlled clinical trials:

 

Body system

Incidence

Reported adverse event

Nervous system disorders

Very common:

Headache

Vascular disorders

 Common:

 

Hypertension*

 

Respiratory, thoracic and mediastinal disorders

Common:

Dyspnoea

Skin and subcutaneous tissue disorders

Common:

 

 

 

 

 

Hypertrichosis (unwanted non-scalp hair including facial hair growth in women), pruritus, rash, (including rash pruritic and application site, pustular, papular, generalized vestibular and macular rash), eye pruritus acneform, dermatitis (including contact, application site, allergic, atopic and seborrhoeic dermatitis) and inflammatory skin disorder.

 

General disorders and administration site conditions

Common:

 

 

 

Oedema peripheral

 

 

Psychiatric disorders

Common:

Depression

 

Muscoskeletal

Common

Muscoskeletal pain

Miscellaneous

Common:

Pain

* This adverse event was identified during a clinical trial for Minoxidil Foam

The following adverse events were associated with post marketing experience:

 

Body system

Incidence

Reported adverse event

Nervous system disorders

Rare

Headache

Vascular disorders

Uncommon

 

Hypotension

 

Cardiovascular disorders

Rare:

Palpitations

Increased heart rate

Chest pain

 

Skin and subcutaneous tissue disorders

Uncommon:

 

 

 

 

 

Hypertrichosis (unwanted non-scalp hair including facial hair growth in women), temporary hair loss, changes in hair texture and hair colour, skin exfoliation, dry skin and rash.

Rare

Contact dermatitis

General disorders and administration site conditions

Uncommon:

 

 

Rare

Application site irritation and application site pruritis

 

Application site erythema.

 

 

Body System (SOC)

Frequency

Adverse Drug Reaction (Preferred Term)

Immune system disorders

 

Not known

 

Allergic contact dermatitis

Not known

Angioedema

 

Hypersensitivity

 

Psychiatric disorders

Common

Depression

 

Nervous system disorders

Very common

 

Headache

Uncommon

Dizziness

 

Eye disorders

Not known

Eye irritation (including eye pruritus)

 

CardiovascularCardiac disorders

Rare

Chest pain

 

Increased hHeart rate increased (Tachycardia)

 

Palpitations

 

Vascular disorders

Common

 

Hypertension*

 

UncommonNot known

Hypotension

 

Respiratory, thoracic and mediastinal disorders

Common

 

Dyspnoea

Gastrointestinal disorders

Uncommon

Nausea

 

nNot known

Vomiting

 

Skin and subcutaneous tissue disorders

Common

Dermatitis (including atopic and seborrhoeic dermatitis)

 

Dermatitis acneiform

 

Hypertrichosis (unwanted non-scalp hair including facial hair growth in women)

 

Pruritus

 

Rash (including rash pruritic, pustular, papular, generalised vestibular and macular)

 

UncommonNot known

Changes in hHair colour changes

 

Changes in hHair texture abnormal

 

Temporary hair loss

Rare

Contact dermatitis

Musculoskeletal and connective tissue disorders

Common

Musculoskeletal pain

 

General disorders and administration site conditions

Common

 

Oedema peripheral

 

Uncommon

Application site irritation

 

Application site pruritus

 

Rare

 

Application site erythema

 

Not known

Application site reactions (These sometimes involve nearby structures like the ears and face and typically consist of pruritus, irritation, pain, rash, oedema, dry skin and erythema but can sometimes be more severe and include exfoliation, dermatitis, blistering, bleeding and ulceration)

 

Investigations

Common

Weight increased*

 

Miscellaneous

Common

Pain

* This adverse event was identified during clinical trials with Minoxidil Foam

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie

 

4.9       Overdose

 

Signs and symptoms

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of Regaine Extra Strength are applied to larger surface areas of the body or areas other than the scalp.  There is no evidence that topically applied minoxidil is absorbed in sufficient quantity to cause systemic effects. When used as directed, overdose is unlikely.

 

Because of the concentration of minoxidil in Regaine Extra Strength, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (2ml of Regaine Extra Strength contains 100mg; the maximum recommended adult dose for oral minoxidil administration in the treatment of hypertension)..

 

If this product is applied to an area of decreased integrity of the epidermal barrier caused by trauma, inflammation, or disease process in the skin, there is a potential for a systemic overdose effect.

 

The following very rare adverse events may occur due to the systemic effects of minoxidil;

 

Very Rare: (< 1/10,000)

Cardiovascular disorders: Heart rate increased, hypotension

General Disorders: Fluid retention resulting in weight increase

Nervous System Disorders: Dizziness

 

Treatment

Treatment of minoxidil overdosage should be symptomatic and supportive. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

 

4.9       Overdose

 

Signs and symptoms

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of Regaine Extra Strength are applied to larger surface areas of the body or areas other than the scalp which therefore may lead to adverse events

 

There is no evidence that topically applied minoxidil is absorbed in sufficient quantity to cause systemic effects. When used as directed, overdose is unlikely.

 

Overdose due to oral administration or excessive systemic exposure of minoxidil exaggerates its cardiovascular effects and may present as hypotension, tachycardia and lethargy.

 

Because of the concentration of minoxidil in Regaine Extra Strength, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (2ml of Regaine Extra Strength contains 100mg; the maximum recommended adult dose for oral minoxidil administration in the treatment of hypertension)..

 

If this product is applied to an area of decreased integrity of the epidermal barrier caused by trauma, inflammation, or disease process in the skin, there is a potential for a systemic overdose effect.

 

The following very rare adverse events may occur due to the systemic effects of minoxidil;

 

Very Rare: (< 1/10,000)

Cardiovascular disorders: Heart rate increased, hypotension

General Disorders: Fluid retention resulting in weight increase

Nervous System Disorders: Dizziness

 

Treatment

Treatment of minoxidil overdosage should be symptomatic and supportive. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

 

5.3       Preclinical safety data

 

None that are relevant to human safety.

 

5.3       Preclinical safety data

 

Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential.

 

Mutagenicity

 

Minoxidil showed no evidence of mutagenic/genotoxic potential in a number of in vitro and in vivo assays.

 

Carcinogenicity

 

A high incidence of hormone-mediated tumours was observed in mice and rats. These tumours are due to the secondary hormonal (hyperprolactinemia) effects observed only in the rodents at extremely high doses by a mechanism similar to that seen with reserpine.

 

Application of topical minoxidil has not demonstrated any effect on hormonal status in women. Therefore, hormonally mediated tumour promotion by minoxidil does not represent a carcinogenic risk to humans.

 

Teratogenicity

 

Animal reproduction toxicity studies in rats and rabbits have shown signs of maternal toxicity and a risk to the foetus at exposure levels that are very high compared to those intended for human use.

 

Fertility

 

Minoxidil doses greater than 9 mg/kg (at least 25-fold human exposure) administered subcutaneously in rats were associated with reduced conception and implantation rates as well as reduction in the number of live pups.

None that are relevant to human safety.

 

6.6       Instructions for use/handling

           

None.

 

6.6       Instructions for use/handlingSpecial precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

           

The solution is flammable and exposure of the container and contents to naked flames should be avoided during use, storage and disposal.

None.

 

Updated on 1 July 2016 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about missed dose
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to warnings or special precautions for use

Updated on 26 February 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 (posology and method administration): Reference to rub on applicator removed

Section 4.3 (contraindications): CI  re. hypersensitivity re-worded.
Section 4.4 (special warnings and precautions before use): Added ' Minoxidil should only be used on a normal healthy scalp. Do not use if scalp is red, inflamed, infected or painful or if using other medications on the scalp. ' and 'Accidental ingestion may cause serious cardiac adverse events.  Therefore, this product has to be kept out of the reach of children.'

Section 4.5 (Interactions): Changed to ‘Pharmacokinetic drug interaction studies in humans revealed percutaneous minoxidil absorption is enhanced by tretinoin and anthralin as a result of increased stratum corneum permeability; betmethasone dipropionate increases local tissue concentrations of minoxidil and decreases systemic minoxidil absorption.’

Section 4.6 (pregnancy and lactation): Added ‘There are no adequate and well controlled studies in pregnant women. Animal studies have shown a risk to the fetus at exposure levels that are very high compared to those intended for human exposure. A low, albeit remote, risk of fetal harm is possible in humans. Topical minoxidil should only be used during pregnancy or lactation if the benefit to the mother outweighs the potential risk to the fetus or nursing infant’

Section 4.8 (undesirable effects): More side effects added and split between those associated with  placebo controlled clinical trials and those associated with post marketing experience.

Section 4.9 (overdose): Added ‘There is no evidence that topically applied minoxidil is absorbed in sufficient quantity to cause systemic effects. When used as directed, overdose is unlikely.

If this product is applied to an area of decreased integrity of the epidermal barrier caused by trauma, inflammation, or disease process in the skin, there is a potential for a systemic overdose effect.

The following very rare adverse events may occur due to the systemic effects of minoxidil; Very Rare: (< 1/10,000):  Cardiovascular disorders: Heart rate increased, hypotension.  General Disorders: Fluid retention resulting in weight increase. Nervous System Disorders: Dizziness.  Treatment section changed to: Treatment of minoxidil overdosage should be symptomatic and supportive. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Section 6.5 (nature and contents of container): Reference to rub on applicator removed

Updated on 26 February 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 5 October 2011 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In Section 6.4, a special storage precaution has been added:
"This medicinal product is flammable"

Updated on 1 March 2011 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update SCP to align wioth CCDS

Section 4.3:
Contraindications now reads:

in users with a history of sensitivity to minoxidil, ethanol, or propylene glycol

in users with treated or untreated hypertension

in users with any scalp abnormality (including psoriasis and sunburn)

in users with a shaved scalp

if occlusive dressings or other topical medical preparations are being used.


Section 4.4

Added:

 

Minoxidil is only indicated for the treatment of alopecia androgenetica and should not be used in other types of hair loss for example when there is no family history of hair loss, hair loss is sudden and/or patchy, hair loss is due to childbirth or the reason for hair loss is unknown.

 

The patient should stop using Regaine Extra Strength and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heart-beat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp.

 

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine Extra Strength.


Hands should be washed thoroughly after applying the solution. Inhalation of the spray mist should be avoided.

Regaine Extra Strength Topical Solution contains ethanol (alcohol), which will cause burning and irritation of the eye.  In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water. Propylene Glycol, contained in this product, may cause skin irritation.


Some consumers reported increased hair shedding upon initiation of therapy with Regaine Extra Strength. This is most likely due to minoxidil’s action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (>2 weeks), users should stop using Regaine Extra Strength and consult their doctor.


Section 4.8

Now formatted by Medra terminology.


Updated on 28 February 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 22 September 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1: Name change: Rogaine to Regaine

Section 2:

Added:
 

“Excipients-Contains Propylene Glycol 500mg/ml”

 

Followed by

 

“For a full list of excipients, see section 6.1”

Section 6.5 "Not all packs sizes may be marketed" added.

Section 10: changed to September 2010

Updated on 20 September 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change to product name

Updated on 13 January 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.3 Shelf life changed to 3 years

Section 10 changed to January 2010

Updated on 29 July 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

MAH name change from "Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire, Co.Dublin" to "McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland".

Updated on 13 May 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 September 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Updated on 10 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only