Mensifem film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Mensifem
film-coated tablets
Dry extract of rhizome of Cimicifuga racemosa L.
Read this entire leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for use of this medicine as described in this leaflet or as advised by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
- You should consult a doctor if you do not improve after 6 to 8 weeks or if your condition worsens.
Contents of the leaflet
- What Mensifem is and what it is used for
- What you need to know before taking Mensifem
- How to take Mensifem
- Possible adverse effects
- How to store Mensifem
- Contents of the pack and other information
1. What Mensifem is and what it is used for
Mensifem is a herbal medicinal product indicated in adult women for the relief of menopausal discomforts, such as hot flushes and excessive sweating.
You should consult a doctor if your symptoms worsen or do not improve after 6 to 8 weeks (40 to 60 days) of treatment.
2. What you need to know before starting to take Mensifem
Do not take Mensifem
- if you are allergic (hypersensitive) to Cimicifuga racemosa or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor before starting to take Mensifem:
- If you have a history of liver disease. In such case, a liver function test should be performed before starting treatment.
- If you notice signs or develop symptoms suggestive of liver damage (tiredness, loss of appetite, yellowing of the skin or eyes, or severe pain in the upper stomach with nausea and vomiting, or dark urine). Stop taking Mensifem and consult your doctor immediately.
- If vaginal bleeding occurs or if you notice new or unexplained symptoms.
- If you have undergone or are undergoing treatment for breast cancer or other hormone-dependent tumors.
- If you are taking estrogens.
- If symptoms worsen during use of this medicine.
If any of the above situations apply to you, do not take Mensifem without medical prescription.
If symptoms persist or worsen during treatment, consult your doctor or pharmacist.
Children and adolescents
There is no therapeutic indication for the use of Mensifem in the pediatric population for the proposed therapeutic indication.
Taking Mensifem with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Medicines can interact with each other when taken simultaneously. However, no interactions have been reported and no interaction studies have been conducted with Mensifem.
Pregnancy, breastfeeding and fertility
You must not take Mensifem if you are pregnant. It is unknown whether the active substance is excreted in breast milk. Mensifem should not be taken during breastfeeding. If there is any possibility of becoming pregnant, even during menopause, effective contraceptive methods should be used during treatment.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and use of machines
No studies have been conducted on the effects on the ability to drive and use machines.
Mensifem contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Mensifem contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per coated tablet, which is essentially “sodium-free”.
3. How to take Mensifem
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
The usual dose for adult women in menopause is 1 film-coated tablet twice daily, i.e. one tablet in the morning and one in the evening (maximum 2 film-coated tablets per day).
Method of administration:
For oral use. The film-coated tablets should be swallowed whole, without chewing or sucking, with some liquid.
Duration of treatment:
If symptoms persist during treatment with this medicine, consult a doctor or pharmacist.
Mensifem should not be taken for longer than six months consecutively without medical advice.
Use in children and adolescents:
There is no therapeutic interest in using Mensifem in the paediatric population for the proposed therapeutic indication.
Special populations:
There are insufficient data to establish specific dosage recommendations in patients with renal or hepatic impairment.
Patients with a history of liver disease should not take Mensifem without medical advice (see section 2 "Warnings and precautions" and section 4 "Possible side effects").
If you take more Mensifem than you should:
No cases of overdose have been reported. Inform your doctor if you have taken a higher than recommended dose of this medicine. Your doctor will decide which measures need to be taken.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount taken.
If you forget to take Mensifem:
Do not take a double dose to make up for the missed dose. Take the next tablet at your usual time.
If you stop taking Mensifem:
Stopping treatment with Mensifem is generally harmless.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of occurrence of the following adverse effects is unknown:
- The use of products containing cimicifuga rhizome has been associated with hepatic toxicity (including hepatitis, jaundice (yellowing of the skin and eyes), fatigue, loss of appetite, upper abdominal pain with nausea and vomiting, dark urine, and abnormalities in liver function tests).
- Skin allergic reactions (urticaria, pruritus, skin rash).
- Swelling of facial tissues and lower limbs (known as edema).
- Gastrointestinal symptoms (e.g. dyspeptic disorders, diarrhea).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Mensifem
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Keep the blisters in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Mensifem
The active substance is:
2.8 mg of dry extract from Cimicifuga racemosa (L.) Nutt., rhizome (black cohosh) (5-10:1) *1
Extraction solvent: ethanol 58% (v/v)
The other components are calcium hydrogen phosphate dihydrate; ammonium methacrylate copolymer, type A, 3% dispersion (Eudragit RL 30D); red iron oxide (E 172); yellow iron oxide (E 172); lactose monohydrate; polyethylene glycol (macrogol 6000); magnesium stearate (vegetable); potato starch; sodium hydroxide; sorbic acid; talc; titanium dioxide (E 171).
Appearance of the product and contents of the pack
Mensifem film-coated tablets are available in aluminum PVC/PVDC blisters.
Box with 60 film-coated tablets
Box with 90 film-coated tablets
Only some pack sizes may be marketed.
The tablets are terracotta-coloured, round, biconvex, with a smooth surface. The film-coated tablet has a diameter between 7.0 and 7.2 mm.
This medicinal product is authorised in the European Economic Area member states under the following names:
Austria Mensifem Filmtabletten
Belgium, Germany, Luxembourg, Poland, Slovenia, Estonia
Croatia, Denmark, Norway, Sweden Klimadynon
Bulgaria ??????????
Spain, France, Italy Mensifem
Slovakia, Czech Republic Menofem
Latvia Klimadynon 2.8 mg apvalkotas tablets
Lithuania Klimadynon 2.8 mg plėvele dengtos tablets
Marketing Authorisation Holder and Manufacturer
BIONORICA SE
Kerschensteinerstrasse 11-15
92318 Neumarkt
Germany
Telephone: +49 / (0)9181 / 231-90
Fax: +49 / (0)9181 / 231-265
E-mail: [email protected]
Date of the most recent review of this leaflet: December 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/