FEMLAX 10 G ORAL SOLUTION POWDER IN SACHETS

Introduction

Leaflet:information for the user

Femlax10 g powder for oral solution in sachet

macrogol 4000

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist or nurse.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days

Contents of the leaflet:

1. What is Femlax and what is it used for
2. What you need to know before taking Femlax
3. How to take Femlax
4. Possible side effects
5. Storage of Femlax
6. Package contents and additional information

1. What is Femlax and what is it used for

The name of this medication is Femlax powder for oral solution in 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 children over 8 years old.

Any organic disorder should be ruled out before starting treatment. It should be used along with lifestyle changes and a suitable 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.

2. What you need to know before taking 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 suffered from 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.

Treatment includes, among others:

• An increase in the proportion of fiber in the diet (vegetables, whole wheat bread, fruit).
• An increase in water and fruit juice intake.
• An increase in physical activity (exercise, walking...).
• Rehabilitation of the defecation reflex.

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

Do not takeFemlax:

• If you are allergic to Macrogol (= PEG = polyethylene glycol) or to any of the other components of this medication (included 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 may have a gastrointestinal perforation.
• If you have or suspect you may have an 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 in case of no improvement or worsening 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, with liver or kidney problems, or those taking diuretics (medications that facilitate the elimination of liquids). If you are one of these people and experience diarrhea, you should review your electrolyte levels with a blood test.

Hypersensitivity reactions (rash, urticaria, and edema) have been reported with drugs containing macrogol (polyethylene glycol). Exceptional cases of anaphylactic shock have been reported.

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

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

Other medications andFemlax

Tell your doctor or pharmacist if you are taking, have recently taken, 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Femlax can be taken during pregnancy.

Breastfeeding

Femlax can be taken during breastfeeding.

Fertility

It is not expected that Femlax will have an effect on fertility.

Driving and using machines

Femlax has no influence on the ability or skill to handle machinery.

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

Femlaxcontains sulfur dioxide

This medication contains sulfur dioxide. It can rarely cause severe hypersensitivity reactions and bronchospasm.

Femlaxcontains sodium

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

3. How to take Femlax

Follow the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Oral route.

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

1 sachet per day, preferably in the morning.

The effect of Femlax occurs 24-48 hours after administration.

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

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

If the symptoms worsen or persist after 7 days of treatment, you should 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 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.

The 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 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 suffer from 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 Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested)

If you forget to takeFemlax

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

The most serious side effects are allergic reactions (hypersensitivity) that include itching (hives), rash, facial edema (swelling of the face), Quincke's edema (rapid swelling 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 could not be established from the available data. If you notice any of the reactions described above, please do not continue taking this medication 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.

Uncommon (may affect up to 1 in 100 people)

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

Frequency not known (cannot be estimated from the 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

As 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).

Uncommon (may affect up to 1 in 100 people)

• Vomiting
• Bloating
• Nausea

Excessive doses can cause diarrhea, abdominal pain, and vomiting that usually disappear when the dose is reduced or treatment is temporarily interrupted.

Reporting 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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es/

5. Storage of Femlax

Keep this medication out of 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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

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 package contents

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

It is available in packages of 10 and 20 sachets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer:

Casen Recordati, S.L.,

Autovía de Logroño, Km 13,300

50180 Utebo (Zaragoza) Spain

Date of the last revision of this leaflet:

Other sources of information

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/