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MSD Ireland (Human Health) Limited

Red Oak North, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com


Summary of Product Characteristics last updated on medicines.ie: 14/11/2017
SPC Sinemet 12.5mg/50mg, 10mg/100mg, Plus 25mg/100mg & 25mg/250mg


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1. NAME OF THE MEDICINAL PRODUCT

Sinemet 12.5mg/50mg Tablets

Sinemet 10mg/100mg Tablets

Sinemet Plus 25mg/100mg Tablets

Sinemet 25mg/250mg Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet of Sinemet 12.5mg/50mg contains carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa.

Each tablet of Sinemet 10mg/100mg contains carbidopa (equivalent to 10 mg of anhydrous carbidopa) and 100 mg levodopa.

Each tablet of Sinemet Plus 25mg/100mg contains carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 100 mg levodopa.

Each tablet of Sinemet 25mg/250mg contains carbidopa (equivalent to 25 mg of anhydrous carbidopa) and 250 mg levodopa.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Tablets.

Sinemet 12.5mg/50mg: yellow, oval-shaped tablets, one side scored and the other marked '520'. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Sinemet 10mg/100mg: light dapple blue, round tablets, with '647' on one side and plain on the other.

Sinemet Plus 25mg/100mg: yellow, round tablets with '650' on one side and plain on the other.

Sinemet 25mg/250mg: light dapple blue, round tablets, with '654' on one side and plain on the other.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Antiparkinsonian agent.

For treatment of Parkinson's disease and syndrome. Sinemet is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. It is frequently helpful in the management of tremor, dysphagia, sialorrhoea, and postural instability associated with Parkinson's disease and syndrome.

When response to levodopa alone is irregular, and signs and symptoms of Parkinson's disease are not controlled evenly throughout the day, substitution of Sinemet usually reduces fluctuations in response. By reducing some of the adverse reactions produced by levodopa alone, Sinemet permits more patients to obtain adequate relief from the symptoms of Parkinson's disease.

Sinemet may be given to patients with Parkinson's disease and syndrome who are taking vitamin preparations that contain pyridoxine hydrochloride (Vitamin B6).


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4.2 Posology and method of administration

To be taken orally.

The optimum daily dosage of Sinemet must be determined by careful titration in each patient.

Sinemet Tablets are available as:-

Sinemet 12.5mg/50mg containing carbidopa PhEur equivalent to 12.5 mg of anhydrous carbidopa and 50 mg levodopa. Each tablet of Sinemet 12.5mg/50mg is designed to divide in half with minimal pressure.

Sinemet 10mg/100mg containing carbidopa PhEur equivalent to 10 mg of anhydrous carbidopa and 100 mg levodopa.

Sinemet Plus containing carbidopa PhEur equivalent to 25 mg of anhydrous carbidopa and 100 mg levodopa.

Sinemet 25mg/250mg containing carbidopa PhEur equivalent to 25 mg of anhydrous carbidopa and 250 mg levodopa.

General Considerations

Dosage should be titrated to individual patient needs, and this may require adjusting both the individual dose and the frequency of administration.

Studies show that the peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. The formulations of Sinemet are designed to provide a range of doses with sufficient carbidopa to inhibit peripheral dopa-decarboxylase and thus exert optimal therapy.

Standard antiparkinsonian drugs, other than levodopa alone, may be continued while Sinemet is being administered, although their dosage may have to be adjusted.

Usual initial dosage

Dosage is best initiated with one tablet of Sinemet Plus three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage equivalent of eight tablets of Sinemet Plus a day is reached.

Sinemet 12.5 mg/50 mg or Sinemet 10 mg/100 mg may be used to facilitate dosage titration according to the needs of the individual patient.

If Sinemet 10mg/100mg or Sinemet 12.5mg/50mg is used, dosage may be initiated with one tablet three or four times a day. However, this may not provide the optimal amount of carbidopa needed by many patients. Titration upward may be required in some patients to achieve optimum dosage of carbidopa. The dosage may be increased by one tablet every day or every other day until a total of eight tablets (two tablets four times a day) is reached.

Response has been observed in one day, and sometimes after one dose. Fully effective doses usually are reached within seven days as compared to weeks or months with levodopa alone.

How to transfer patients from Levodopa

Because both therapeutic and adverse responses occur more rapidly with 'Sinemet' than when levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with 'Sinemet' than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

Discontinue levodopa at least 12 hours (24 hours for slow-release preparations of levodopa) before starting therapy with Sinemet. A daily dosage of 'Sinemet' should be chosen that will provide approximately 20% of the previous levodopa daily dosage.

Patients who are taking less than 1,500 mg of levodopa a day should be started on one tablet of Sinemet Plus three or four times a day. The suggested starting dosage for most patients taking more than 1,500 mg of levodopa is one tablet of Sinemet 25mg/250mg three or four times a day.

Maintenance

Therapy with Sinemet should be individualised and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided for optimal inhibition of extracerebral decarboxylation of levodopa. When a greater proportion of carbidopa is required, one tablet of Sinemet Plus 25 mg/100 mg or Sinemet 12.5 mg/50 mg may be substituted for each tablet of Sinemet 10 mg/100 mg.

Sinemet Plus may be helpful, especially for patients with nausea and vomiting.

When more levodopa is required, Sinemet 25mg/250mg should be substituted for Sinemet Plus 25 mg/100 mg or Sinemet 10 mg/100 mg, or Sinemet 12.5 mg/50 mg. If necessary, the dosage of Sinemet 25mg/250mg may be increased by one tablet every day or every other day to a maximum of eight tablets a day. Experience with total daily dosages of carbidopa greater than 200 mg carbidopa is limited.

Maximum recommended dose

Eight tablets of Sinemet 25 mg/250 mg per day (200 mg of carbidopa and 2 g of levodopa). This is about 3 mg/kg of carbidopa, and 30 mg/kg of levodopa in a patient weighing 70 kg.

Patients receiving levodopa with another decarboxylase inhibitor

When transferring a patient to Sinemet from levodopa combined with another decarboxylase inhibitor, its dosage should be discontinued at least 12 hours before Sinemet is started. Begin with a dosage of Sinemet that will provide the same amount of levodopa as contained in the other levodopa/decarboxylase inhibitor combination.

Use in children

The safety of Sinemet in patients under 18 years of age has not been established and its use in patients below the age of 18 is not recommended.

Use in the elderly

In the elderly, dosage should generally be low with slow and minimal increments.


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4.3 Contraindications

Non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with Sinemet. These inhibitors must be discontinued at least two weeks before starting therapy with Sinemet. Sinemet may be administered concomitantly with the manufacturer's lowest recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline hydrochloride). (See 4.5 'Interactions with other medicinal products and other forms of interaction').

Sinemet is contraindicated in patients with narrow-angle glaucoma and in patients with known hypersensitivity to any component of this medication.

Since levodopa may activate a malignant melanoma, Sinemet should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.

Use during pregnancy or lactation and in women breast-feeding infants (see 4.6 'Fertility, pregnancy and lactation').

Use in patients with severe psychoses.


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4.4 Special warnings and precautions for use

Sinemet is not recommended for the treatment of drug-induced extrapyramidal reactions.

Sinemet should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage).

Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered.

All patients should be monitored carefully for the development of mental changes, depression with concomitant suicidal tendencies, and other serious antisocial behaviour. Patients with past or current psychoses should be treated with caution.

Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction.

Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone should be observed carefully when Sinemet is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa, and use of Sinemet may cause a recurrence. Dosage reduction may be required.

A syndrome resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, mental changes and increased serum creatine phosphokinase has been reported with the abrupt withdrawal of antiparkinsonian agents. Therefore, patients should be observed carefully when the dosage of Sinemet is reduced abruptly or discontinued especially if the patient is receiving neuroleptics.

If concomitant administration of psycho-active drugs such as phenothiazines or butyrophenones is necessary, such drugs should be administered with caution, and the patient carefully observed for loss of antiparkinsonian effect.

Patients with a history of convulsions should be treated with caution.

As with levodopa, periodic evaluation of hepatic, haematopoetic, cardiovascular and renal function are recommended during extended therapy.

Patients with chronic wide-angle glaucoma may be treated cautiously with Sinemet, provided the intra-ocular pressure is well controlled and the patient monitored carefully for changes in intra-ocular pressure during therapy.

Care should be exercised when Sinemet is administered to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. Cardiac function should be monitored with particular care in such patients during the period of initial dosage adjustment.

Melanoma: Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson's disease or other factors, such as drugs used to treat Parkinson's disease, is unclear.

For the reasons stated above, patients and providers are advised to monitor for melanomas frequently and on a regular basis when using SINEMET for any indication. Ideally, periodic skin examinations should be performed by appropriately qualified individuals (e.g., dermatologists).

If general anaesthesia is required, therapy with Sinemet may be continued for as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the usual daily dosage may be administered as soon as the patient is able to take oral medication.

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder resulting in excessive use of the product seen in some patients treated with carbidopa/ levodopa. Before initiation of treatment, patients and caregivers should be warned of the potential risk of developing DDS (see also section 4.8).

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Sinemet. Review of treatment is recommended if such symptoms develop.

Laboratory Tests

Transient abnormalities in laboratory test results may occur, but have not been associated with clinical evidence of disease. These include elevations of blood urea nitrogen, AST (SGOT), ALT (SGPT), LDH, bilirubin, creatinine, uric acid, and alkaline phosphatase.

Commonly, levels of blood urea nitrogen, creatinine, and uric acid are lower during administration of Sinemet than with levodopa.

Decreased haemoglobin and haematocrit; elevated serum glucose; and white blood cells, bacteria and blood in the urine have been reported.

Positive Coombs' tests have been reported, both with Sinemet and levodopa alone, but haemolytic anaemia is extremely rare.

Sinemet may cause a false positive result for ketonuria when a dipstick is used to test for urinary ketone bodies; and this reaction is not altered by boiling the urine specimen. The use of glucose oxidase methods may give false negative results for glycosuria.


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4.5 Interaction with other medicinal products and other forms of interaction

Caution should be exercised when the following drugs are administered concomitantly with Sinemet.

Antihypertensive agents

Symptomatic postural hypotension has occurred when Sinemet is added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with Sinemet is started, dosage adjustment of the antihypertensive drug may be required.

Antidepressants

Rarely, reactions including hypertension and dyskinesia have been reported with the concomitant use of tricyclic antidepressants. (For patients receiving monoamine oxidase inhibitors, see 4.3 'Contraindications').

Iron

Studies demonstrate a decrease in the bioavailability of carbidopa and/or levodopa when it is ingested with ferrous sulphate or ferrous gluconate.

Other drugs

Dopamine D2 receptor antagonists (eg. phenothiazines, butyrophenones and risperidone, thioxanthenes) and isoniazid may reduce the therapeutic effect of levodopa. The beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Sinemet should be carefully observed for loss of therapeutic response.

Use of Sinemet with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.

Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see 4.3 'Contraindications').

Since levodopa competes with certain amino acids, the absorption of levodopa may be impaired in some patients on a high protein diet.

The effect of simultaneous administration of antacids with Sinemet on the bioavailability of levodopa has not been studied.


4.6 Fertility, pregnancy and lactation

Pregnancy

Although the effects of Sinemet on human pregnancy are unknown, both levodopa and combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits. Therefore, the use of Sinemet in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards should pregnancy occur.

Use of Sinemet is contraindicated in pregnancy.

Breast-feeding

It is not known whether carbidopa is excreted in human milk. In a study of one nursing mother with Parkinson's disease, excretion of levodopa in breast milk was reported. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in infants, a decision should be made whether to discontinue breast-feeding or discontinue the use of Sinemet, taking into account the importance of the drug to the mother.


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4.7 Effects on ability to drive and use machines

No data are known about the effect on the ability to drive. If side effects such as dizziness or somnolence occur, they may affect the ability to drive and to operate machinery.

Patients being treated with levodopa and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also 4.4 'Special warnings and precautions for use').


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4.8 Undesirable effects

Side effects that occur frequently with Sinemet are those due to the central neuropharmacological activity of dopamine. These reactions can usually be diminished by dosage reduction. The most common are dyskinesias including choreiform, dystonic and other involuntary movements and nausea. Muscle twitching and blepharospasm may be taken as early signs to consider dosage reduction.

Other side effects reported in clinical trials or in post-marketing experience include:

The frequencies of adverse events are ranked according to the following: Very common (≥ 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1000, < 1/100), Rare (≥ 1/10,000, < 1/1000), Very Rare (< 1/10,000) including isolated reports.

Metabolism and nutrition disorders:

Common: Anorexia

Psychiatric disorders:

Common: Dream abnormalities, hallucinations, depression with or without development of suicidal tendencies, confusion.

Uncommon: Agitation.

Rare: Psychotic episodes including delusions and paranoid ideation, increased libido.

Nervous system disorders:

Common: Bradykinetic episodes (the “on-off” phenomenon), dizziness, somnolence including very rarely excessive daytime somnolence and sudden sleep onset, paresthesia.

Uncommon: Syncope

Rare: Dementia, neuroleptic malignant syndrome (see 4.4 'Special warnings and precautions for use'). Rarely convulsions have occurred; however, a causal relationship with Sinemet has not been established.

Cardiac disorders:

Common: Palpitation.

Rare: Cardiac irregularities.

Vascular disorders:

Common: Orthostatic effects including hypotensive episodes.

Rare: Hypertension, phlebitis.

General disorders and administration site conditions:

Common: Chest pain.

Gastrointestinal disorders:

Common: Diarrhoea, vomiting.

Rare: Gastrointestinal bleeding, development of duodenal ulcer, dark saliva.

Blood and lymphatic system disorders:

Rare: Leukopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.

Respiratory, thoracic and mediastinal disorders:

Common: Dyspnoea.

Skin and subcutaneous disorders:

Uncommon: Urticaria.

Rare: Angioedema, pruritis, Henoch-Schönlein purpura, alopecia, rash, dark sweat.

Renal and urinary disorders:

Rare: Dark urine.

Other side effects that have been reported with levodopa or levodopa/carbidopa combinations and may be potential side effects with Sinemet include:

Neoplasms, benign, malignant and unspecified (including cysts and polyps):

Malignant melanoma (see section 4.3 'Contraindications').

Gastro-intestinal disorders:

Dry mouth, sialorrhoea, dysphagia, hiccups, dyspepsia, abdominal pain and distress, constipation, flatulence, burning sensation of the tongue.

Metabolism and nutrition disorders:

Weight gain or loss.

Psychiatric disorders:

Anxiety, disorientation, euphoria, insomnia, bruxism, Dopamine Dysregulation Syndrome.

Dopamine Dysregulation Syndrome (DDS) is an addictive disorder seen in some patients treated with carbidopa/ levodopa. Affected patients show a compulsive pattern of dopaminergic drug misuse above doses adequate to control motor symptoms, which may in some cases result in severe dyskinesias (see also section 4.4).

Impulse control disorders: Pathological (compulsive) gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Sinemet (see section 4.4 'Special warnings and precautions for use').

Nervous system disorders: Bitter taste, decreased mental acuity, ataxia, numbness, increased hand tremor, activation of latent Horner's syndrome, extrapyramidal and movement disorders, faintness, headache, sense of stimulation.

Skin and subcutaneous disorders:

Increased sweating.

Musculoskeletal, connective tissue and bone disorders:

Muscle cramps, trismus.

Eye disorders:

Diplopia, blurred vision, dilated pupils, oculogyric crises.

Vascular disorders:

Hot flashes, flushing.

Respiratory, thoracic and mediastinal disorders:

Hoarseness, bizarre breathing patterns.

Renal and urinary disorders:

Urinary retention, urinary incontinence.

Reproductive system and breast disorders:

Priapism.

General disorders:

Weakness, asthenia, fatigue, malaise, oedema, gait abnormalities.

Injury, poisoning and procedural complications:

Falling.

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.


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4.9 Overdose

Management of acute overdosage with Sinemet is basically the same as management of acute overdosage with levodopa; however pyridoxine is not effective in reversing the actions of Sinemet. ECG monitoring should be instituted, and the patient carefully observed for the possible development of arrhythmias; if required, appropriate anti-arrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Sinemet should be taken into consideration.

To date, no experience has been reported with dialysis, and hence its value in the treatment of overdosage is not known.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Dopa and dopa derivatives, ATC code: N04BA02.

Levodopa is a precursor of dopamine, and is given as replacement therapy in Parkinson's disease.

Carbidopa is a peripheral dopa decarboxylase inhibitor. It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine acts. A lower dose of levodopa can be used, reducing the incidence and severity of side effects.


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5.2 Pharmacokinetic properties

Following oral dosing levodopa, in the absence of decarboxylase inhibitor, is rapidly but variably absorbed from the gastrointestinal tract. It has a plasma half life of about 1 hour and is mainly converted by decarboxylation to dopamine, a proportion of which is converted to noradrenaline. Up to 30 % is converted to 3-O-methyldopa which has a half life of 9 to 22 hours. About 80 % of levodopa is excreted in the urine within 24 hours mainly as homovanillic acid and dihydroxyphenylactic acid. Less than 1 % is excreted unchanged.

Once in the circulation it competes with other neutral amino acids for transport across the blood brain barrier. Once it has entered the striatal neurones it is decarboxylated to dopamine, stored and released from presynaptic neurones. Because levodopa is so rapidly decarboxylated in the gastrointestinal tract and the liver very little unchanged drug is available for transport into the brain. The peripheral decarboxylation reduces the therapeutic effectiveness of levodopa but is responsible for many of its side effects. For this reason levodopa is usually administered together with a peripheral decarboxylase inhibitor such as carbidopa so that lower doses may be given to achieve the same therapeutic effect.

Carbidopa is rapidly but incompletely absorbed from the gastrointestinal tract following oral dosing. Following an oral dose approximately 50% is recorded in the urine with about 30 % of this as unchanged drug. It does not cross the blood brain barrier but crosses the placenta and it is not known whether carbidopa is excreted in human milk. Turnover of the drug is rapid and virtually all unchanged drug appears in the urine within 7 hours.

Carbidopa inhibits the peripheral decarboxylation of levodopa to dopamine but as it does not cross the blood brain barrier, effective brain levels of dopamine get produced with lower levels of levodopa therapy reducing the peripheral side effects noticeably nausea and vomiting and cardiac arrhythmias.


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5.3 Preclinical safety data

Sinemet is well established in medical use. Preclinical data is broadly consistent with clinical experience. For reproductive toxicity, see 4.6 'Fertility, pregnancy and lactation'.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sinemet 12.5mg/50mg tablets contain quinoline yellow (E104), maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate

Sinemet Plus 25 mg/100 mg Tablets contain quinoline yellow aluminium lake (E104), hydroxypropyl cellulose, pregelatinised starch, crospovidone, microcrystalline cellulose, magnesium stearate.

Sinemet 10mg/100mg & Sinemet 25mg/250mg tablets contain FD&C Blue #2/indigo carmine aluminium lake (E132), hydroxypropyl cellulose, pregelatinised starch, crospovidone, microcrystalline cellulose, magnesium stearate.


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

Sinemet 12.5mg/50mg:

3 years.

Sinemet Plus 25 mg/100 mg, Sinemet 10mg/100mg & Sinemet 25mg/250mg:

2 years.


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6.4 Special precautions for storage

Sinemet 12.5mg/50mg:

Bottles:

Do not store above 25°C. Keep the bottle tightly closed. Store in the original package.

Blisters:

Do not store above 25°C. Store in the original package in order to protect from light.

Sinemet Plus 25 mg/100 mg, Sinemet 10mg/100mg & Sinemet 25mg/250mg:

This medicinal product does not require any special storage conditions.


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6.5 Nature and contents of container

Sinemet 12.5mg/50mg:

HDPE bottle of 84 or 100 tablets.

PVC/AL blister packs of 30 or 90 tablets.

Not all pack sizes may be marketed.

Sinemet Plus 25 mg/100 mg, Sinemet 10mg/100mg & Sinemet 25mg/250mg:

AL/AL blister packs of 100 tablets.


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6.6 Special precautions for disposal and other handling

Not applicable.


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7. MARKETING AUTHORISATION HOLDER

Merck Sharp & Dohme Ireland (Human Health) Limited

Red Oak North

South County Business Park

Leopardstown

Dublin 18

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

Sinemet 12.5mg/50mg Tablets:

Sinemet 10mg/100mg Tablets:

Sinemet Plus 25mg/100mg Tablets:

Sinemet 25mg/250mg Tablets:

PA 1286/9/2

PA 1286/9/3

PA 1286/9/4

PA 1286/9/5


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Sinemet 12.5mg/50mg Tablets: 8 February 1990 / 1 April 2009

Sinemet 10mg/100mg Tablets: 1 April 1979 / 1 April 2009

Sinemet Plus 25mg/100mg Tablets: 2 March 1981 / 1 April 2009

Sinemet 25mg/250mg Tablets: 1 April 1979 / 1 April 2009


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10. DATE OF REVISION OF THE TEXT

October 2017



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Active Ingredients

 
   Levodopa
   Carbidopa