Femlax 10 g powder for oral solution in sachets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Femlax 10 g powder for oral solution in sachet
macrogol 4000
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for administration of this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse.
- Keep this leaflet as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Contents of the leaflet:
- What Femlax is and what it is used for
- What you need to know before taking Femlax
- How to take Femlax
- Possible adverse effects
- How to store Femlax
- Contents of the pack and other information
1. What Femlax is and what it is used for
The name of this medicine is Femlax powder for oral solution in sachet.
This medicine contains Macrogol (PEG = Polyethylene glycol) 4000.
Femlax is considered an osmotic laxative.
Femlax is used for the symptomatic relief of occasional constipation in adults and children over 8 years of age.
An organic disorder should have been ruled out before starting treatment. It should be used together with lifestyle changes and an appropriate diet (see section 2). It should not be used for longer than 1 week of treatment unless advised by a doctor.
You should consult your doctor if your condition worsens or if you do not improve after 7 days.
2. What you need to know before starting to take Femlax
Occasional constipation:
Occasional constipation may be related to a recent change in lifestyle. There are medications that can be used for short-term treatment. Consult your doctor if you have recently experienced constipation not due to changes in your lifestyle, or constipation associated with abdominal pain, fever, or abdominal swelling.
Chronic constipation (long-term constipation):
Chronic constipation may be caused by:
- Intestinal disease requiring medical consultation.
- Intestinal dysfunction (imbalance) due to dietary habits and lifestyle.
Treatment includes, among others:
- Increasing the proportion of fiber in the diet (vegetables, wholemeal bread, fruit).
- Increasing fluid and fruit juice intake.
- Increasing physical activity (exercise, walking, etc.).
- Rehabilitation of the defecation reflex.
If symptoms persist despite dietary measures, an underlying cause should be considered and treated.
Do not take Femlax:
- If you are allergic to Macrogol (= PEG = polyethylene glycol) or to any of the other ingredients of this medicine (listed in section 6).
- If you have an intestinal or colonic disease (such as ulcerative colitis, Crohn's disease) or toxic megacolon associated with symptomatic stenosis.
- If you have abdominal pain of unknown cause.
- If you have or suspect gastrointestinal perforation.
- If you have or suspect intestinal obstruction (ileus).
- Femlax must not be administered to children under 8 years of age.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to take Femlax.
Patients should consult a doctor if there is no improvement or if symptoms worsen after 7 days of treatment.
Due to the mechanism of action of macrogol, fluid intake is recommended during treatment with this medicine.
In case of diarrhoea, some patients may develop electrolyte disturbances (reduction of certain salts in the blood), particularly elderly patients, those with liver or kidney problems, or those taking diuretics (medications that promote fluid elimination). If you belong to any of these groups and experience diarrhoea, your electrolyte levels should be checked via a blood test.
Hypersensitivity reactions (rash, urticaria, and oedema) have been reported with medicinal products containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.
Use with caution in patients with impaired gag reflex, patients prone to regurgitation or aspiration, and in patients with swallowing difficulties. In such cases, consult your doctor.
Avoid mixing Femlax with starch-based thickeners if you have swallowing difficulties. This may result in an aqueous liquid that could enter your lungs and cause pneumonia if you are unable to swallow properly.
Other medicines and Femlax
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Femlax may delay the absorption of other medicines, making them less effective or ineffective, especially those with a narrow therapeutic index (e.g., antiepileptics, digoxin, and immunosuppressants).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Femlax may be taken during pregnancy.
Breastfeeding
Femlax may be taken during breastfeeding.
Fertility
Femlax is not expected to have an effect on fertility.
Driving and use of machines
Femlax has no influence on the ability to drive or operate machinery.
Femlax contains a negligible amount of sugar or polyols, and can therefore be prescribed to diabetic patients or patients on a galactose-free diet.
Femlax contains sulphur dioxide
This medicine contains sulphur dioxide. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
Femlax contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; hence, it is essentially “sodium-free”.
3. How to take Femlax
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Oral use.
The recommended dose for adults and children over 8 years of age is:
1 sachet per day, preferably in the morning.
The effect of Femlax occurs within 24–48 hours after administration.
The daily dose should be adjusted according to the effect of the medicine and may range from one sachet every two days (especially in children), and if the initial dose is not effective, it may be increased up to 2 sachets per day.
If treatment proves effective, it is recommended to reduce the dose to the lowest effective dose. Treatment should be discontinued gradually.
If symptoms worsen or persist after 7 days of treatment, consult your doctor.
Dissolve the contents of the sachet in a glass of water (at least 125 ml) immediately before administration and drink the liquid. The resulting solution will be clear and transparent like water.
It is recommended to drink 125 ml of fluid (e.g. water) after each dose.
Improvement in intestinal transit after administration of Femlax will be maintained by following a healthy lifestyle and diet.
Use in children and adolescents
Femlax is contraindicated in children under 8 years of age.
If you take more Femlax than you should
You may develop diarrhea, abdominal pain, and vomiting, which resolve when treatment is temporarily interrupted or the dose is reduced.
If you experience severe diarrhea or vomiting, you should contact your doctor as soon as possible, as fluid loss may require treatment to prevent loss of salts (electrolytes).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).
If you forget to take Femlax
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The most serious adverse effects are allergic reactions (hypersensitivity) including pruritus (rash), eruption, facial oedema (swelling of the face), angioedema (rapid swelling of the skin layers), urticaria, and anaphylactic shock. The frequency of these adverse effects has been reported as very rare (may affect 1 in 10,000 people) in the adult population, while in the paediatric population the frequency could not be established from the available data. If you experience any of the reactions described above, please stop taking this medicine immediately and contact your doctor without delay.
Adults
Generally, adverse effects are mild and transient, and mainly affect the gastrointestinal system. These adverse effects include:
Frequent (may affect up to 1 in 10 people)
- Abdominal pain
- Abdominal distension
- Diarrhoea
- Nausea
Uncommon (may affect up to 1 in 100 people)
- Vomiting
- Urgent need to defecate
- Faecal incontinence
Frequency not known (cannot be estimated from available data)
- Electrolyte disturbances: low levels of sodium and potassium in the blood (hyponatremia and hypokalemia)
- Dehydration caused by severe diarrhoea, especially in elderly patients
- Erythema
Children and adolescents
As in the adult population, adverse effects are generally mild and transient and mainly affect the gastrointestinal system. These adverse effects include:
Frequent (may affect up to 1 in 10 people)
- Abdominal pain
- Diarrhoea (may cause perianal pain)
Uncommon (may affect up to 1 in 100 people)
- Vomiting
- Bloating
- Nausea
Excessive doses may cause diarrhoea, abdominal pain, and vomiting, which usually resolve when the dose is reduced or treatment is temporarily discontinued.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Femlax
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Do not use this medicine if you notice any visible signs of deterioration.
Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Package contents and other information
Composition of Femlax
- The active substance is Macrogol 4000. Each sachet contains 10 g of macrogol 4000.
- The other components are sodium saccharin (E954) and apple flavour (natural flavour, maltodextrin, arabic gum (E-414), sulfur dioxide (E-220), alpha-tocopherol (E-307)). See section 2 “Femlax contains sulfur dioxide”.
Appearance of the product and contents of the pack
Femlax is an almost white powder contained in a sachet for making a solution.
It is available in packs of 10 and 20 sachets.
Only some pack sizes may be commercially available.
Marketing Authorisation Holder and Manufacturer:
Casen Recordati, S.L.,
Autovía de Logroño, Km 13,300
50180 Utebo (Zaragoza), Spain
Date of the most recent revision of this leaflet:
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/