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ALVERINE MAYOLY SPINDLER 60 MG HARD CAPSULES - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - ALVERINE MAYOLY SPINDLER 60 MG HARD CAPSULES

GIELISM 60 mg hard capsules

Alverine citrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

  • 1. What GIELISM is and what it is used for

  • 2. What you need to know before you take GIELISM

  • 3. How to take GIELISM

  • 4. Possible side effects

  • 5. How to store GIELISM

  • 6. Contents of the pack and other information

1. what gielism is and what it is used for

GIELISM is an anti-spasmodic medicine. It relaxes the muscles in the intestine (gut) and uterus (womb). This helps stop the pain you feel when the muscles become tense.

GIELISM is used:

  • to help people who have Irritable Bowel Syndrome (IBS). Some of the symptoms of IBS are:

  • – abdominal pains like cramp which come and go,

  • – diarrhoea,

  • – constipation,

  • – feeling full and bloated,

  • – wanting to go to the toilet urgently.

Sometimes these symptoms are worse if you are worried or under stress.

  • for a condition of the large intestine called painful diverticular disease of the colon.
  • to relieve period pains.

GIELISM is intended for adults and adolescents over 12 years old.

2. what you need to know before you take gielism if you are allergic to the active substance (alverine citrate) or any of the other ingredients of this medicine (listed in section 6).

  • If your doctor has told you that you have obstruction of the gut or that your small bowel is not working properly.

Precautions and warnings

If any of the following apply to you, you should not take GIELISM, as it may not be the right treatment for you. See your doctor as soon as possible if:

  • you are aged 40 years or over.
  • you have passed blood from the bowel.
  • you are feeling sick or vomiting.
  • you have lost your appetite or lost weight.
  • you are looking pale and feeling tired.
  • you are suffering from severe constipation.
  • you have a fever.
  • you have recently travelled abroad
  • you have abnormal vaginal bleeding or discharge.
  • you have difficulty or pain passing urine.

Consult your doctor if you have developed new symptoms, or if your symptoms worsen, or if they do not improve after 2 weeks treatment.

Children

GIELISM is not suitable for children under 12 years old.

Other medicines and GIELISM

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Taking GIELISM with food

It does not matter if you take GIELISM with or without food.

Pregnancy, breast-feeding and fertility

You should not use this medicine if you are pregnant or if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you feel dizzy while taking GIELISM you should avoid driving or operating machinery.

3. how to take gielismalways take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 or 2 capsules taken up to 3 times a day.

Method of administration

Swallow the capsule with a glass of water.

Duration of treatment

Consult your doctor if your symptoms do not improve after 2 weeks treatment.

If you take more GIELISM than you should, contact a doctor.

If you forget to take GIELISM, take it when you remember. If you forget for more than 4 hours, just take the next dose when you remember it is due.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking GIELISM and see your doctor as soon as possible if you notice:

  • Difficulties in breathing, shortness of breath, wheezing, swelling of your face or other parts of your body, as serious allergic reactions have been known to occur.
  • Yellowing of the whites of the eyes and the skin, as inflammation of the liver has been known to occur.

Other side effects may include:

  • a feeling of sickness or dizziness,
  • headache,
  • allergic reactions, which may include itching or skin rash.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Reporting of side effects

If tou get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store gielism

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 blister pack and on the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What GIELISM contains

  • The active substance is: 60 mg alverine citrate.
  • The other ingredients are: pregelatinised starch, magnesium stearate. Composition of the capsule shell: gelatin, titanium dioxide (E171).

What GIELISM looks like and contents of the pack

GIELISM is available in PVC/Aluminium blisters.

Each pack contains 3, 10, 12, 20, 30, 60, 90 or 100 hard capsules in blisters. The hard capsules are white and oblong.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Laboratoires Mayoly Spindler

6 avenue de l’Europe

B.P.51

78401 Chatou Cedex

France

Manufacturer

SOPHARTEX

  • 21, rue du Pressoir

F-28500 Vernouillet

France

Health tips for you

Try to make your everyday life a bit healthier:

  • Allow plenty of time to do things, and avoid stress
  • Do not rush meals
  • Try to eat a balanced diet with high fibre foods
  • Do not eat foods which seem to make your IBS worse

This medicinal product is authorised in the Member States of the EEA under the following names:

Ireland: Gielism

This leaflet was last revised in {MM/YYYY}.

To request a copy of this leaflet in Braille, large print or audio format, please contact licence holder at the address above.

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

A ALIMENTARY TRACT AND METABOLISM DRUGS

A03 DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

A03A DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

A03AX Other drugs for functional gastrointestinal disorders in ATC

A03AX08 alverine

Frequently Asked Questions

What is Alverine Mayoly Spindler and how does it work?

Alverine Mayoly Spindler is a medication that helps relieve symptoms of abdominal pain and discomfort caused by spastic conditions in the intestines. It works by relaxing the muscles in the gut.

What conditions can Alverine Mayoly Spindler treat?

Alverine Mayoly Spindler is commonly used to treat irritable bowel syndrome (IBS) and other gastrointestinal disorders that involve muscle spasms.

How should I take Alverine Mayoly Spindler capsules?

You should take Alverine Mayoly Spindler capsules as directed by your doctor, usually one capsule three times a day, swallowed whole with a glass of water.

Can I take Alverine Mayoly Spindler with food?

Yes, you can take Alverine Mayoly Spindler with or without food. However, taking it with food may help reduce any potential stomach upset.

Are there any common side effects of Alverine Mayoly Spindler?

Some common side effects include nausea, headache, and dizziness. If you experience any severe side effects, contact your healthcare provider immediately.

Is Alverine Mayoly Spindler safe for everyone?

Alverine Mayoly Spindler is not recommended for individuals with certain medical conditions or allergies. Always consult your healthcare provider before starting this medication.

Can I drink alcohol while taking Alverine Mayoly Spindler?

It's best to avoid alcohol while taking Alverine Mayoly Spindler, as it can increase the risk of side effects such as dizziness or drowsiness.

How long does it take for Alverine Mayoly Spindler to start working?

Many patients feel relief from symptoms within a few hours of taking the capsule, but individual responses may vary based on the severity of symptoms.

What should I do if I miss a dose of Alverine Mayoly Spindler?

If you miss a dose, take it as soon as you remember. If it's almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double up.

Can I take Alverine Mayoly Spindler during pregnancy or breastfeeding?

Consult your healthcare provider before taking Alverine Mayoly Spindler if you are pregnant or breastfeeding to ensure it is safe for you and your baby.

How should I store Alverine Mayoly Spindler capsules?

Store Alverine Mayoly Spindler capsules at room temperature away from moisture and heat. Keep out of reach of children.

What should I do in case of an overdose of Alverine Mayoly Spindler?

If you suspect an overdose, seek medical attention immediately or contact your local poison control center for guidance.

Can children take Alverine Mayoly Spindler capsules?

Alverine Mayoly Spindler is generally not recommended for children under 12 years old. Always consult a pediatrician before giving any medication to children.

Will Alverine Mayoly Spindler interact with other medications I'm taking?

Alverine may interact with certain medications. Make sure to inform your healthcare provider about all medications you are currently taking before starting this treatment.

Can lifestyle changes improve my condition while using Alverine Mayoly Spindler?

Yes! Alongside using Alverine, adopting a healthy diet, managing stress levels, and regular exercise may help improve symptoms associated with IBS.

What lifestyle habits should I avoid while taking Alverine Mayoly Spindler?

Try to avoid excessive caffeine intake, smoking, and high-fat foods which may exacerbate gastrointestinal symptoms while on this medication.

Is there a specific diet I should follow when using Alverine Mayoly Spindler?

While on this medication, consider keeping a food diary to identify triggers and focus on a balanced diet rich in fiber to help manage IBS symptoms.

How can I tell if my symptoms are improving while taking this medication?

Keep track of any changes in abdominal pain frequency and intensity; improvement often includes fewer episodes of discomfort or bloating after meals.

Where can I find more information about IBS treatments including Alverine Mayoly Spindler?

For more information about IBS treatments like Alverine, consult reputable medical websites or speak directly with your healthcare provider for personalized advice.