Jak stosować MOLAXOLE
Treść ulotki
Molaxole powder for oral solution
macrogol 3350
sodium chloride
sodium bicarbonate
potassium chloride
equivalent medicine
Read this leaflet carefully before taking this medicine as it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:
- 1. What Molaxole is and what it is used for
- 2. What you need to know before you use Molaxole
- 3. How to use Molaxole
- 4. Possible side effects
- 5. How to store Molaxole
- 6. Contents of the pack and other information
1. What is Molaxole and what is it used for
Molaxole helps you to have adequate bowel movement even if you have had a long period of
constipation. After consulting your doctor, you can also use Molaxole for the treatment of
persistent constipation (called fecal occlusion).
Macrogol 3350 increases the volume of feces by binding with water, leading to a
normalization of colon motility. The physiological consequences are an improved propulsive transport
of softened feces and ease of defecation. The salts present in the formulation help to
maintain the normal water and electrolyte balance of the body.
You should see a doctor if you do not feel better or if you feel worse after 2 weeks of constipation. If you are
being treated for very severe constipation (called fecaloma) you must follow your doctor's instructions.
2. What you need to know before using Molaxole
Do not take Molaxole
- if you are allergic to any of the active ingredients macrogol, sodium chloride, potassium chloride or sodium bicarbonate or to any of the other ingredients of this medicine (listed in section 6);
- if you have an intestinal obstruction, a perforation of the intestinal walls or a severe inflammatory disease of the gastrointestinal tract such as ulcerative colitis, Crohn's disease, ileus or toxic megacolon.
Warnings and precautions
Talk to your doctor or pharmacist before using Molaxole.
During the intake of Molaxole you must continue to drink plenty of fluids. The fluid content of
Molaxole should not replace normal fluid intake.
If you develop side effects such as swelling, shortness of breath, fatigue, dehydration (symptoms include
increased thirst, dry mouth and weakness) or heart problems, you should stop taking Molaxole and talk
immediately to your doctor.
If, for example, you are taking medicines that cause constipation or if you suffer from diseases that cause constipation such as
Parkinson's disease or multiple sclerosis (MS) do not take Molaxole for longer periods of time than
those established, unless you have had specific instructions from your doctor.
Children
Do not administer this medicine to children under 12 years of age.
Other medicines and Molaxole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Some medicines, such as antiepileptics, may not work effectively during the use of
Molaxole. Therefore, you should not take other medicines by mouth together with Molaxole and one hour before and
one hour after taking Molaxole.
Molaxole can interact with starch-based food thickeners, causing the liquefaction of preparations
that need to remain dense for people with swallowing problems. Molaxole should be used with
caution when used with starch-based thickeners.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Molaxole can be used during pregnancy and breastfeeding.
Driving and operating machinery
There are no effects on driving or operating machinery
Molaxole contains sodium
This medicine contains 187 mg of sodium (the main component of table salt) per sachet. This
is equivalent to 9.5% of the maximum recommended daily intake with the diet of an adult.
3. How to use Molaxole
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose for constipation is:
1 sachet 1-3 times a day. The normal dose for most patients is 1-2 sachets a day. Depending on
individual response, 3 sachets a day may be necessary. The dose depends on the
severity of your constipation.
The dose may be reduced to the lowest effective dose after a couple of days. The duration of treatment is
normally 2 weeks. If symptoms persist after 2 weeks of treatment, consult your doctor.
Dissolve the contents of one sachet in half a glass of water (approximately 125 ml). Mix until
the powder has dissolved and drink. If you wish, you can add fruit juice or fruit syrup just before
drinking.
Children (under 12 years of age):not recommended.
The recommended dose for fecal occlusion is:
Adults: the usual dose is 8 sachets per day. The 8 sachets must be taken within a period of 6 hours
each day for no more than 3 days if required. A treatment cycle for fecal occlusion normally does not exceed
3 days. If you use Molaxole for the treatment of fecal occlusion, dissolve 8 sachets in
one liter of water. The solution can then be stored in the refrigerator.
Patients with compromised cardiovascular function:
For the treatment of fecal occlusion, the dose must be divided so as not to take more than two
sachets in one hour.
Patients with renal insufficiency:
It is not necessary to modify the dose for the treatment of both constipation and fecal occlusion.
If you take more Molaxole than you should
If you take too much Molaxole and have severe diarrhea or start vomiting, stop taking Molaxole until
the disturbances stop, then you can start again with a lower dose. If you are worried, contact your
doctor or pharmacist.
If you forget to take Molaxole
Do not take a double dose to make up for a missed dose.
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Molaxole can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):Stomach pain and cramps, diarrhoea, vomiting,
nausea, rumbling stomach and gastrointestinal gas problems.
Common (may affect up to 1 in 10 people):Itching, headache, swelling of hands, feet or ankles.
Uncommon (may affect up to 1 in 100 people):Skin reactions, digestive disorders and swollen stomach.
Very rare (may affect up to 1 in 10,000 people):Severe allergic reactions causing difficulty in
breathing, or swelling of the face, lips, tongue or throat. If you experience any of these symptoms,
inform your doctor immediately and stop taking Molaxole. Allergic reactions (for example,
skin reactions and runny nose), high and low levels of potassium in the blood and anal discomfort.
Not known (frequency cannot be estimated from available data):changes in the levels of
fluids or electrolytes in the body (low levels of sodium).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By
reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Molaxole
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and on the package after “Exp.”.
The expiry date refers to the last day of that month.
This product does not require any particular storage temperature.
Store in the original package to protect from humidity. The reconstituted solution can be
stored well covered in a refrigerator (2°C – 8°C). Discard any unused solution within a period
of 6 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
6. Contents of the pack and other information
What Molaxole contains
- The active ingredients are macrogol 3350 (also known as polyethylene glycol 3350) 13.125 g, sodium chloride 350.7 mg, sodium bicarbonate 178.5 mg, potassium chloride 46.6 mg.
- The other ingredients are: acesulfame potassium (E950) (sweetener) and lemon aroma (flavouring).
Description of Molaxole and contents of the pack
White powder for oral solution.
Sachets of 13.8 g in a box of 2, 6, 8, 10, 20, 30, 40, 50, 60 and 100 or 2x50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Healthcare Limited
Damastown Industrial Park Mulhuddart,
Dublin 15
DUBLIN,
Ireland
Manufacturer
Klocke Pharma-Service GmbH, Strassburger Strasse 77, D-77762 Appenweier (Germany)
Lamp San Prospero S.p.A.,Via Della Pace 25/a, San Prospero, 41030, Italia
For any information on this medicine, contact the local representative of the Marketing Authorisation Holder.
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) with the following denominations:
Denmark, Norway, Finland, Hungary, Iceland and Sweden: Moxalole
Austria, Belgium, Cyprus, Ireland, Italy, Luxembourg, Portugal, Spain, Netherlands and United Kingdom:
Molaxole
Poland: Duphagol
- Kraj rejestracji
- Postać farmaceutycznaOral solution powder
- Kod ATCA06AD65
- Substancja czynna
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki MOLAXOLEPostać farmaceutyczna: Oral solution powder, 6.9 GSubstancja czynna: macrogol, combinationsProducent: ITALFARMACO S.P.A.Bez receptySubstancja czynna: macrogol, combinationsProducent: ALFASIGMA S.P.A.Wymaga receptyPostać farmaceutyczna: Oral solution powder, 17,5 GSubstancja czynna: macrogol, combinationsProducent: ALFASIGMA S.P.A.Wymaga recepty
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MOLAXOLE wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
Substancją czynną w MOLAXOLE jest macrogol, combinations. Informacja ta pomaga rozpoznać leki o tym samym składzie, ale pod różnymi nazwami handlowymi.
MOLAXOLE jest produkowany przez Viatris Healthcare Limited. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie MOLAXOLE jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
Polska posiada dobrze rozwiniętą infrastrukturę ochrony zdrowia w dużych miastach, takich jak Warszawa, Kraków, Wrocław i Gdańsk. Apteki są łatwo dostępne i działają zgodnie z obowiązującymi przepisami, zapewniając dostęp do leków na receptę.
Możesz kupić MOLAXOLE w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną (macrogol, combinations) to m.in. BENLAXID, KLENSIA, KOLIREI. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















