Activelle

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/03/16

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Summary of Product Characteristics last updated on medicines.ie: 16/3/2016
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Novo Nordisk Limited

Novo Nordisk Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Activelle Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Actrapid 100 international units/ml, Solution for injection in a vial Active Ingredients Human Insulin
Medicine Name Estrofem 2mg Active Ingredients Estradiol Hemihydrate
Medicine Name Fiasp 100 units-mL solution for injection in Cartridge Penfill Active Ingredients Insulin aspart
Medicine Name Fiasp 100 units-mL solution for injection in pre-filled FlexTouch pen Active Ingredients Insulin aspart
Medicine Name Fiasp 100 units-mL solution for injection in vial Active Ingredients Insulin aspart
Medicine Name GlucaGen HypoKit 1 mg powder and solvent for solution for injection Active Ingredients Glucagon hydrochloride
Medicine Name Insulatard 10 ml Vial Active Ingredients Human Insulin
Medicine Name Insulatard InnoLet Active Ingredients Human Insulin
Medicine Name Insulatard Penfill Active Ingredients Human Insulin
Medicine Name Insulatard, Insulatard Penfill, Insulatard InnoLet Active Ingredients Human Insulin
Medicine Name Kliogest 2 mg/1 mg film-coated tablets Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name Levemir FlexPen (Insulin detemir) 100 units/ml solution for injection in pre-filled pen Active Ingredients insulin detemir
Medicine Name Levemir InnoLet (Insulin detemir) 100 units/ml solution for injection in pre-filled pen Active Ingredients insulin detemir
Medicine Name Levemir Penfill (Insulin detemir) 100 units/ml solution for injection in cartridge Active Ingredients insulin detemir
Medicine Name Norditropin FlexPro 10 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin FlexPro 15 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin FlexPro 5 mg/1.5 ml solution for injection in pre-filled pen Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 10 mg/1.5 ml, solution for injection Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 15 mg/1.5 ml, solution for injection Active Ingredients Somatropin
Medicine Name Norditropin SimpleXx 5 mg/1.5 ml, solution for injection in cartridge Active Ingredients Somatropin
Medicine Name Novofem film-coated tablets Active Ingredients Estradiol Hemihydrate, Norethisterone acetate
Medicine Name NovoMix 30 FlexPen Active Ingredients Insulin aspart
Medicine Name NovoMix 30 Penfill Active Ingredients Insulin aspart
Medicine Name NovoNorm 0.5 mg, 1 mg and 2 mg tablets Active Ingredients Repaglinide
1 - 0 of 40 items.Total: Infinity pages

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 16 March 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 16 March 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.4 Special warnings and precautions for use

Ovarian cancer

Ovarian cancer is much rarer than breast cancer. Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8). Some studies, including the WHI trial, suggest that the long-term use of combined HRT may confer a similar or slightly smaller risk (see section 4.8).Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only or combined oestrogen-progestagen HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.

Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see section 4.8).

 

4.8 Undesirable effects

Ovarian cancer risk

Long-term useUse of oestrogen-only andor combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer. In the Million Women Study, 5 years of HRT resulted in 1 extra case per 2,500 users. diagnosed (see section 4.4).

A meta-analysis from 52 epidemiological studies reported an increased risk of ovarian cancer in women currently using HRT compared to women who have never used HRT (RR 1.43, 95% CI 1.31-1.56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2,000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2,000 will be diagnosed with ovarian cancer over a 5-year period.

 

10.       DATE OF REVISION OF THE TEXT

March 201503/2016

 

 

 

Updated on 11 March 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 March 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 24 November 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 12 March 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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:

 

Ireland

HPRA Pharmacovigilance IMB Pharmacovigilance

 

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie   www.imb.ie

e-mail: medsafety@hpra.ie   imbpharmacovigilance@imb.ie .

 

10.     DATE OF REVISION OF THE TEXT

 

March 2015 July 2014

 

Updated on 9 March 2015 PIL

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 22 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each film-coated tablet contains:

 

Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg.

 

Excipient with known effect: lactose monohydrate.

 

For thea full list of excipients, see section 6.1.

 

 

3.       PHARMACEUTICAL form

 

Film-coated tablets.

 

White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the APISApis bull on the other.

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4.2     Posology and method of administration

 

Activelle is a continuous combined HRThormone replacement product intended for use in women with an intact uterus.

 

One tablet should be taken orally once a day without interruption, preferably at the same time every day.

 

For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used.

 

A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for satisfactory symptom relief.

 

In women with amenorrhoea and not taking HRT or women transferring in transition from another continuous combined HRT product, treatment with Activelle may be started on any convenient day. In women transferring in transition from a sequential HRT regimens, treatment should start right after their withdrawal bleeding has ended.

 

If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours hashave passed, the tablet should be discarded. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.


--------------

Endometrial hyperplasia and carcinoma

 

In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among oestrogen-only users varies from 2- to 12-fold greater compared with non-users, depending on the duration of treatment and oestrogen dose (see section 4.8). After stopping treatment, the risk may remain elevated for more than 10 years.


-----------

Breast cancer

 

The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestagen and possibly also oestrogen-only HRT that is dependent on the duration of taking HRT.

 

The randomised placebo-controlled trial, the Women’s Health Initiative study (WHI), and epidemiological studies are consistent in finding an increased risk of breast cancer in women taking combined oestrogen-progestagen for HRT becomes apparent after about 3 years (see section 4.8).

 

The excess risk becomes apparent after about 3 within a few years of use, but returns to baseline within a few (at most 5) years after stopping treatment.


----------------

Oestrogens increase thyroid binding globulin (TBG), leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels (by radioimmunoassay). T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Other binding proteins may be elevated in serum, i.e. corticoid binding globulin (CBG), sex-hormone-binding globulin (SHBG) leading to increased circulating corticosteroids and sex steroids, respectively. Free or biological active hormone concentrations are unchanged. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-I-antitrypsin and ceruloplasmin).

 

HRT use does not improve cognitive function. There is some evidence of increased risk of probable dementia in women who start using continuous combined or oestrogen-only HRT after the age of 65.

 

Activelle contains tablets contain lactose monohydrate. Patients with rare hereditary heredity problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

-------------------

Ritonavir, telaprevir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John’s Wort (Hypericum perforatum) may induce the metabolism of oestrogens and progestagens.


----------

If pregnancy occurs during medication with Activelle, treatment should be withdrawn immediately.

Clinically, data on a limited number of exposed pregnancies indicate adverse effects of norethisterone on the foetus. At doses higher than those normally used in OC and HRT formulations, masculinisation of female foetuses was observed.

---------

Fertility

 

No data available.

--------------
#

 

-    Neoplasms benign and malignant (including cysts and polyps): Endometrial cancer

–        Immune system disorders: Generalised hypersensitivity reactions (e.g. anaphylactic reaction/shock)

–        Psychiatric disorders: Insomnia, anxiety, libido decreased, libido increased

–        Nervous system disorders: Dizziness, stroke

–        Eye disorders: Visual disturbances

–        Cardiac disorders: Myocardial infarction

–        Vascular disorders: Hypertension aggravated

–        Gastrointestinal disorders: Dyspepsia, vomiting

–        Hepatobiliary Hepatobilitary disorders: Gallbladder disease, cholelithiasis, cholelithiasis aggravated, cholelithiasis recurrence reoccurrence

–        Skin and subcutaneous tissue disorders: Seborrhoea, rash, angioneurotic oedema

–        Reproductive system and breast disorders: Hyperplasia endometrial Endometrial hyperplasia, vulvovaginal pruritus

–        Investigations: Weight decreased, blood pressure increased.

 

Other adverse reactions have been reported in association with oestrogen/progestagen treatment:

–        Skin and subcutaneous disorders: Alopecia, chloasma, erythema multiforme, erythema nodosum, vascular purpura

–        Probable dementia over the age of 65 (see section 4.4).

-------------------

 

Million Women Study – Estimated additional risk of breast cancer after 5 years’ use

 

Age range (years)

Additional caesIncidence per 1,000 never-users of HRT over a 5 year period 5 years*

Risk ratio** and 95% CI

Additional cases per 1,000 HRT users over 5 years use (95% CI)

Oestrogen-only HRT

50-65

9-12

1.2

1-2 (0-3)

Combined oestrogen-progestagen

50-65

9-12

1.7

6 (5-7)

* Taken from baseline incidence rates in developed countries.

** Overall risk ratio. The risk ration is not constant but will increase with increasing duration on use.

Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionatelyproportionally.

 

US WHI Studies – Additional risk of breast cancer after 5 years’ use

 

Age range (years)

Incidence per 1,000 women in placebo arm over 5 years

Risk ratio and 95% CI

Additional cases per 1,000 HRT users over 5 years’ use (95% CI)

CEE oestrogen-only

50-79

21

0.8 (0.7-1.0)

-4 (-6-0)*

CEE+MPA oestrogen-progestagen**

50-79

17 14

1.2 (1.0-1.5)

4 (0-9)

-----------------

 

Ovarian cancer risk

Long-term use of oestrogen-only and combined oestrogen-progestagenprogestogen HRT has been associated with a slightly increased risk of ovarian cancer. In the Million Women Study, 5 years of HRT resulted in 1 extra case per 2,500 users.

------------------

 

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:

 

Ireland

IMB Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

------------------

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: progestagenprogestogen and oestrogens, fixed combinations, ATC code: G03FA01.

 

Mechanism of action

 

Estradiol: The active ingredient, synthetic 17betaβ-estradiol, is chemically and biologically identical to endogenous human estradiol. It substitutes for the loss of oestrogen production in postmenopausal women, and alleviates menopausal symptoms.

Oestrogens prevent bone loss following menopause or ovariectomy.

 

Norethisterone acetate: Synthetic progestagen with actions similar to those of progesterone, a natural female sex hormone. As oestrogens promote the growth of the endometrium, unopposed oestrogens increase the risk of endometrial hyperplasia and cancer. The addition of a progestagen greatly reduces the oestrogen-induced risk of endometrial hyperplasia in non-hysterectomised women.

 

Pharmacodynamic effects

 

In clinical trials with Activelle, the addition of the norethisterone acetate component enhanced the vasomotor symptom relieving effect of 17betaβ-estradiol.

 

Relief of menopausal symptoms is achieved during the first few weeks of treatment.

 

Activelle is a continuous combined HRT given with the intent of avoiding the regular withdrawal bleeding associated with cyclic or sequential HRT. Amenorrhoea (no bleeding or spotting) was seen in 90% of the women during months 9-12 of treatment. Bleeding and/or spotting appearedwas observed in 27% of the women during the first 3 months of treatment and in 10% during months 10-12 of treatment.

-------------------

 

Absorption and distribution of 17β-estradiol

 

Following oral administration of 17betaβ-estradiol in microniszed form, rapid absorption from the gastrointestinal tract occurs. It undergoes extensive first-pass metabolism in the liver and other enteric organs, and reaches a peak plasma concentration of approximately 35 pg/ml (range 21-52 pg/ml) within 5-8 hours. The half-life of 17betaβ-estradiol is about 12-14 hours. It circulates bound to SHBG (37%) and to albumin (61%), while only approximately 1-2% is unbound.

 

Biotransformation and elimination of 17β-estradiol

Metabolism of 17β-estradiol, occurs mainly in the liver and the gut but also in target organs, and involves the formation of less active or inactive metabolites, including oestrone, catecholoestrogens and several oestrogen sulfphates and glucuronides. Oestrogens are excreted withby the bile, where they are hydrolysed and reabsorbed (enterohepatic circulation), and mainly eliminated in urine in biologically inactive form.

 

Absorption and distribution of norethisterone acetate

 

----------

 

Biotransformation and elimination of norethisterone acetate

 

The most important metabolites are isomers of 5α-dihydro-NET and of tetrahydro-NET, which are excreted mainly in the urine as sulfphate or glucuronide conjugates.

---------------

The acute toxicity of oestrogens is low. Because of marked differences between animal species and between animals and humans, preclinical results possess a limited predictive value for the application of oestrogens in humans.

 ----------------

Date of latest renewal: 6th March 2013 6th March 2008

10.     DATE OF REVISION OF THE TEXT

 

 

July 2014

 

 

Updated on 18 July 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to date of revision

Updated on 26 July 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2            Qualitative and Quantitative Composition
        word "anhydros" deleted
4.1       Therapeutic indications

Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses.
4.3 Contraindications
Sentence added:

Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency (see section 4.4))

4.4  Special warnings and precautions for use

 Sentences added:

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

Endometrial hyperplasia and carcinoma

 In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods. The reported increase in endometrial cancer risk among oestrogen-only users varies from 2- to 12-fold greater compared with non-users, depending on the duration of treatment and oestrogen dose (see section 4.8). After stopping treatment risk may remain elevated for more than 10 years.

Breast Cancer
Sentence added and information deleted

Breast cancer

 The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen-progestagen and possibly also oestrogen-only HRT, that is dependent on the duration of taking HRT.

Added:
Ovarian cancer

 Ovarian cancer is much rarer than breast cancer. Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8). Some studies, including the WHI trial, suggest that the long-term use of combined HRTs may confer a similar or slightly smaller risk (see section 4.8).


Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. HRT is therefore contraindicated in these patients (see section 4.3).

In women with no personal history of VTE but with a first degree relative with a history of thrombosis at a young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).

 

If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe’ (e.g. antithrombin, protein S, or protein C deficiencies or a combination of defects), HRT is contraindicated.

 

Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.

Coronary artery disease (CAD)  - information added and deleted

The relative risk of CAD during use of combined oestrogen-progestagen HRT is slightly increased. As the baseline absolute risk of CAD is strongly dependent on age, the number of extra cases of CAD due to oestrogen-progestagen use is very low in healthy women close to menopause, but will rise with more advanced age.

 

Combined oestrogen-progestagen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).

Venous thromboembolism  information added and deleted

Patients with known thrombophilic states have an increased risk of VTE and HRT may add to this risk. HRT is therefore contraindicated in these patients (see section 4.3).


In women with no personal history of VTE but with a first degree relative with a history of thrombosis at a young age, screening may be offered after careful counselling regarding its limitations (only a proportion of thrombophilic defects are identified by screening).

 

If a thrombophilic defect is identified which segregates with thrombosis in family members or if the defect is ‘severe’ (e.g. antithrombin, protein S, or protein C deficiencies or a combination of defects), HRT is contraindicated.

 

Women already on chronic anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.


Coronary artery disease (CAD)
information added dn deleted

The relative risk of CAD during use of combined oestrogen-progestagen HRT is slightly increased. As the baseline absolute risk of CAD is strongly dependent on age, the number of extra cases of CAD due to oestrogen-progestagen use is very low in healthy women close to menopause, but will rise with more advanced age.

Ischaemic stroke

Combined oestrogen-progestagen and oestrogen-only therapy are associated with an up to 1.5-fold increase in risk of ischaemic stroke. The relative risk does not change with age or time since menopause. However, as the baseline risk of stroke is strongly age-dependent, the overall risk of stroke in women who use HRT will increase with age (see section 4.8).

Revision date: June 2011


Updated on 6 July 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 12 July 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section  4.4 Special Warnings and Precautions for Use

Previous wording: Long term (at least 5-10 years) use of oestrogen-only HRT products in hysterectomised women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is uncertain whether long-term use of combined HRT confers a different risk than oestrogen-only products.

New wording: Long-term (at least 5 or 10 years) use of oestrogen-only HRTs and oestrogen plus progestogen HRTs has been associated with an increased risk of ovarian cancer in some epidemiological studies.

Section 4.8 Undesirable effects

Ovarian cancer

New addition:  Long-term use of oestrogen-only and combined oestrogen-progestogen HRT may slightly increase the risk of ovarian cancer, as reported in some epidemiological studies (see Section 4.4)

New addition: Immune system disorder: Hypersensitivity (to post marketing experience)

Section 10
 Amendment of date to January 2009.

Updated on 10 February 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 January 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 September 2008 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The date of revision of the text (section 10) has been updated due to approval of a renewal.

Updated on 20 July 2006 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 1

“Film-coated tablet” added

 

Change to section 2

The following has been added:

Each film-coated tablet contains:

For excipients, see 6.1”

 

Change to section 3

The following has been added:

White film-coated, round, biconvex tablets with a diameter of 6 mm.  The tablets are engraved with NOVO 288 on one side and the APIS on the other.

 

Change to section 4.1

Addition of the following statement on osteoporosis:

Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

 

Change to section 4.2

Addition of statements regarding revised SPC guidelines.

 

Change to section 4.3

Pregnancy moved to section 4.6

Arterial thromboembolic disease and Porphyria added.

 

Change to section 4.4

This section has been updated in line with revised SPC guidelines.

Inclusion of statement on lactose.

 

Change to section 4.5

This section has been updated in line with revised SPC guidelines.

 

Change to section 4.6

Further information on pregnancy and lactation included.

 

Change to section 4.8

This section has been updated in line with revised SPC guidelines.

 

Change to section 5.1

Editorial changes.

 

Change to section 5.3

Additional preclinical data included.

 

Change to section 6.3

Shelf-life increased from 2 years to 3 years.

 

Change to section 6.4

Updated inline with use of standard terms.

 

Change to section 6.6

Instructions for use removed and new statement “No special requirements” added.

 

Change to section 9

Date of renewal included

 

Change to section 10

Date of revision of the text amended

 

 

 

 

Updated on 18 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 30 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)