Normonlax powder for oral solution
Spain
Table of Contents
Package Leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Normonlax powder for oral solution
Macrogol 3350 / sodium chloride / sodium bicarbonate / potassium chloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Normonlax is and what it is used for
- What you need to know before taking Normonlax
- How to take Normonlax
- Possible side effects
- How to store Normonlax
- Contents of the pack and other information
1. What Normonlax is and what it is used for
The name of this medicine is Normonlax powder for oral solution. It is a laxative used for the treatment of constipation in adults, adolescents, and elderly people. It is not recommended for children under 12 years of age.
Normonlax helps you achieve proper intestinal transit, even if you have been constipated for a long time. Normonlax is also effective in resolving fecal impaction, a complication of severe constipation.
2. What you need to know before starting to take Normonlax
Do not take Normonlax
- If your doctor has told you have:
- Intestinal obstruction
- Intestinal perforation
- Severe inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or toxic megacolon
- If you are allergic to macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride or to any of the other components of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Normonlax if:
- You have epilepsy or a history of seizures
- You have heart failure, severe kidney problems, or are taking medicines for blood pressure
When taking Normonlax, you must continue to drink plenty of fluids. The liquid content of Normonlax does not replace your normal fluid intake.
If you experience vomiting (with blood) followed by sudden chest, neck, or abdominal pain, difficulty swallowing, or difficulty breathing after taking Normonlax, stop taking the medicine and contact your doctor immediately.
Heart conditions
Follow the instructions in section 3 if you are taking Normonlax for fecal impaction
If you develop sudden abdominal pain or rectal bleeding while taking Normonlax for bowel preparation, contact your doctor or seek immediate medical attention.
Other medicines and Normonlax
Some medicines, such as antiepileptic drugs, may be less effective when taken together with Normonlax. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding, and fertility
Normonlax can be used during pregnancy and breastfeeding.
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.
Driving and using machines
Normonlax does not affect the ability to drive or operate machinery.
Normonlax contains potassium, sodium, and sorbitol
Patients with kidney failure or those on potassium-restricted diets should be aware that this medicine contains 26.39 mg (0.675 mmol) of potassium per sachet.
This medicine contains 186.87 mg of sodium (the main component of cooking/table salt) in each sachet. This is equivalent to 9.3% of the maximum daily recommended intake of sodium for an adult.
This medicine contains 0.760 mg of sorbitol per sachet.
3. How to take Normonlax
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
How to take this medicine
This medicine can be taken at any time without the need to accompany it with food. Dissolve the contents of each sachet in 125 ml (1/2 glass) of water and take it.
Constipation:
One dose of Normonlax corresponds to one sachet dissolved in 125 ml (1/2 glass) of water. Take this amount 1 to 3 times a day depending on the degree of constipation you have.
Fecal impaction:
Before taking Normonlax for fecal impaction, a doctor must confirm that you are in this condition.
A dose of 8 sachets per day is required for the treatment of fecal impaction. Each sachet must be dissolved in 125 ml (1/2 glass) of water. The 8 sachets should be taken within a six-hour period and for up to 3 days if necessary. If you have heart problems, do not take more than 2 sachets in one hour.
How to prepare Normonlax
Open the sachet and pour the contents into a glass. Add about 125 ml (1/2 glass) of water and stir well until the powder has completely dissolved, resulting in a clear or slightly cloudy solution, then drink it. If you are taking Normonlax for fecal impaction, it will be easier to dissolve the 8 sachets in one liter of water.
Duration of treatment
Constipation:
Treatment normally lasts about 2 weeks. If you need to take Normonlax for longer, consult your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis, or if you are taking medicines that may cause constipation, your doctor may recommend that you take Normonlax for longer than 2 weeks. If you need to take Normonlax for longer, consult your doctor.
For long-term treatment, the dose can usually be reduced to 1 or 2 sachets per day.
Fecal impaction:
Treatment may last up to 3 days.
If you take more Normonlax than you should
You may experience excessive diarrhea, which can lead to dehydration. If this occurs, stop treatment with Normonlax and drink plenty of fluids. If you are concerned, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Normonlax
Take your dose as soon as you remember. Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Immediately inform your doctor and stop treatment with Normonlax if you experience:
- A severe allergic reaction causing difficulty breathing or swelling of the face, lips, tongue, or throat.
- Seizures.
Other adverse effects include:
- Allergic reactions which may cause skin rash, itching, redness of the skin or hives, swelling of hands, feet or ankles, headache, and high or low blood potassium levels.
- Oesophageal rupture due to vomiting, frequency not known.
In some cases, you may experience indigestion, stomach pain or noises.
You may also feel bloated, have gas, nausea or vomiting. You may also experience anal pain and may have mild diarrhoea when you start taking Normonlax. These adverse effects usually improve if the dose of Normonlax is reduced.
If any of these adverse effects become particularly bothersome or last longer than a few days, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Normonlax
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and carton after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Once Normonlax has been dissolved in water, if not taken immediately, store the solution in the refrigerator (between 2 °C and 8 °C). Discard any solution not used within 24 hours.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. Ask your pharmacist how to 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 Normonlax
Each sachet of Normonlax contains the following active substances:
Macrogol 3350 13.125 g
Sodium chloride 0.3507 g
Sodium bicarbonate 0.1785 g
Potassium chloride 0.0466 g
The other components are: lime-lemon flavour, orange flavour, sodium saccharin and anhydrous colloidal silica.
The lime-lemon flavour consists of the following components: natural flavouring preparations, natural flavouring substances, flavouring substances, maltodextrin, mannitol (E421), glucono delta-lactone (E575), sorbitol (E420), gum arabic (E414) and anhydrous colloidal silica (E551).
The orange flavour consists of the following components: flavouring preparations, flavouring substances, natural flavouring substances, maltodextrin, gum arabic (E414) and α-tocopherol (E307).
When one sachet is dissolved in 125 ml of water, the solution contains:
Sodium 65 mmol/l
Potassium 5.4 mmol/l
Chloride 53 mmol/l
Bicarbonate 17 mmol/l
Appearance of the medicine and contents of the pack
Normonlax is a white crystalline powder. Normonlax is available in boxes containing 20 or 30 sachets. Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 – Tres Cantos
Madrid (Spain)
Date of the most recent revision of this leaflet: December 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).