Leaflet:information for the user

Femlax10 g powder for oral solution in sachet

macrogol 4000

The name of this medication is Femlax powder for oral solution in a sachet.

This medication 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 in children over 8 years old.

A organic disorder must be ruled out before starting treatment. It should be used along with lifestyle changes and an adequate diet (see section 2). It should not be used for more than 1 week of treatment, unless advised by a doctor.

You should consult your doctor if it worsens or does not improve after 7 days.

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 pain, fever, or abdominal inflammation.

Chronic Constipation (Long-term Constipation):

Chronic constipation may be caused by:

• Intestinal disease that requires consulting a doctor.
• Intestinal dysfunction (imbalance) due to dietary habits and lifestyle.

The treatment includes, among others:

• Increasing the proportion of fiber in the diet (vegetables, whole bread, fruit).
• Increasing water and fruit juice intake.
• Increasing physical activity (exercise, walking, etc.).
• Rehabilitating the defecation reflex.

If symptoms persist despite dietary measures, an underlying cause should be considered and treated.

Do not takeFemlax:

• If you are allergic to Macrogol (= PEG = polyethylene glycol) or any of the other components of this medication (listed in section 6).
• If you have a disease that affects the intestine or colon (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 you have a gastrointestinal perforation.
• If you have or suspect you have intestinal obstruction (ileus).
• Femlax should not be administered to children under 8 years old.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to take Femlax.

Patients should consult their doctor if they do not observe improvement or worsen after 7 days of treatment.

Due to the mechanism of action of macrogol, it is recommended to drink liquids during treatment with this medication.

In case of diarrhea, some patients may develop electrolyte disorders (decrease in certain salts in the blood), mainly elderly people, those with liver or kidney problems, or those taking diuretics (medications that facilitate the elimination of liquids). If you are any of these people, and experience diarrhea, you should review your electrolyte levels with a blood test.

Severe hypersensitivity reactions (rash, urticaria, and edema) have been reported with macrogol-containing medications. Rare cases of anaphylactic shock have been reported.

Use with caution in patients with altered nausea reflex, patients prone to regurgitation or aspiration, and patients with swallowing problems. In these cases, consult your doctor.

Avoid mixing Femlax with starch-based thickeners if you have swallowing problems. This may result in a watery liquid that could enter your lungs and cause pneumonia if you cannot swallow it properly.

Other Medications and Femlax

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Femlax may delay the absorption of other medications, making them less effective or ineffective, especially those with a narrow therapeutic index (e.g., antiepileptics, digoxin, and immunosuppressants).

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using this medication if you are pregnant, breastfeeding, or plan to become pregnant.

Pregnancy

Femlax can be taken during pregnancy.

Breastfeeding

Femlax can be taken during breastfeeding.

Fertility

No effect on fertility is expected from Femlax.

Driving and Operating Machines

Femlax has no influence on the ability or capacity to operate machinery.

Femlax contains an insignificant amount of sugar or polyols, and can therefore be prescribed to diabetic patients or patients following a galactose-free diet.

Femlax contains sulfur dioxide

This medication contains sulfur dioxide. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

Femlax contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Oral administration.

The recommended dose for adults and children over 8 years old is:

1 tablet per day, preferably in the morning.

The effect of Femlax is produced within 24-48 hours of administration.

The daily dose should be adjusted according to the effect of the medication and may range from one tablet every two days (especially in children) and in case the initial dose is not effective, it can be increased up to 2 tablets per day.

Once the treatment is effective, it is recommended to reduce the dose to the minimum effective dose. The treatment should be gradually discontinued.

If symptoms worsen or persist after 7 days of treatment, consult your doctor.

Dissolve the contents of the tablet in a glass of water (at least 125 ml) immediately before administration and drink the liquid. The result will be a clear and transparent solution like water.

It is recommended to drink 125 ml of liquids (e.g. water) after each dose.

Improvement of 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 old.

If you take moreFemlaxthan you should

You may develop diarrhea, abdominal pain, and vomiting that disappears when treatment is temporarily interrupted or the dose is reduced.

If you experience significant diarrhea or vomiting, you should contact your doctor as soon as possible, as due to fluid loss, you may need treatment to prevent electrolyte loss.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested)

If you forgot to takeFemlax

Do not take a double dose to compensate for the missed dose.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effects are allergic reactions (hypersensitivity) that include pruritus (hives), rash, facial edema (inflammation of the face), Quincke's edema (rapid inflammation of the inner layers of the skin), urticaria, and anaphylactic shock. The frequency of these side effects has been reported as very rare (may affect 1 in 10,000 people) in the adult population and in the pediatric population, the frequency has not been established from the available data. If you notice any of the reactions described above, please do not continue taking this medicine and contact your doctor immediately.

Adults

Generally, side effects are mild and transient, and mainly affect the gastrointestinal system. These side effects include:

Frequent (may affect up to 1 in 10 people)

• Abdominal pain.
• Abdominal distension.
• Diarrhea.
• Nausea.

Rare (may affect up to 1 in 100 people)

• Vomiting.
• Urgent need to go to the bathroom.
• Fecal incontinence.

Unknown frequency (cannot be estimated from available data)

• Electrolyte disorders: low sodium and potassium levels in the blood (hyponatremia and hypokalemia).
• Dehydration caused by severe diarrhea, especially in elderly patients.
• Erythema.

Children and adolescents

Like in the adult population, side effects are generally mild and transient and mainly affect the gastrointestinal system. These side effects include:

Frequent (may affect up to 1 in 10 people)

• Abdominal pain.
• Diarrhea (may cause perianal pain).

Rare (may affect up to 1 in 100 people)

• Vomiting
• Swelling
• Nausea

Overdoses may cause diarrhea, abdominal pain, and vomiting that generally disappear when the dose is reduced or treatment is temporarily interrupted.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Composition ofFemlax

• The active ingredient is Macrogol 4000. Each sachet contains 10 g of macrogol 4000.
• The other components are sodium saccharin (E954) and apple flavor (natural flavor, maltodextrin, gum arabic (E-414), sulfur dioxide (E-220), alpha-tocopherol (E-307)). See section 2 “Femlax contains sulfur dioxide”.

Appearance of the productand contents of the packaging

Femlax is a nearly white powder contained in a sachet to make a solution.

It is available in packaging of 10 and 20 sachets.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Casen Recordati, S.L.,

Autovía de Logroño, Km 13,300

50180 Utebo (Zaragoza) Spain

Date of the last review of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/