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MIZOLLEN 10 MG MODIFIED-RELEASE TABLETS - Patient leaflet, side effects, dosage

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

Patient leaflet - MIZOLLEN 10 MG MODIFIED-RELEASE TABLETS

1. What Mizollen is and what it is used for.


The active ingredient in Mizollen is mizolastine. Mizolastine is an antihistamine.

Mizollen is used to reduce the symptoms of:

  • hay fever (seasonal allergic rhinoconjuncti­vitis)
  • other allergic reactions causing irritation of the eyes and nose (perennial allergic rhinoconjuncti­vitis)
  • urticaria (an itchy skin rash, like nettle rash).

2. What you need to know before you take Mizollen.

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3. how to take mizollen.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

For adults, including the elderly and children aged 12 years and over.

The usual dose is one tablet (10 mg) daily.

The tablets should be taken with plenty of water.

If you take more Mizollen than you should

If you think you have taken too many tablets of Mizollen contact your doctor or nearest hospital emergency department immediately.

If you forget to take Mizollen

If you have forgotten to take a tablet of Mizollen, take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Mizollen

Inform your doctor if you wish to stop your treatment before finishing the course of treatment.

0If 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.

Tell your doctor immediately and stop taking Mizollen if you experience dizziness, swelling of the face, lips, tongue or throat and difficulty in breathing, as these may be signs of a serious allergic reaction.

Common side effects (may affect up to 1 in 10 people):

  • dry mouth, headache, dizziness, drowsiness, lack of energy
  • diarrhoea, nausea
  • stomach pain, indigestion
  • increased appetite associated with weight gain.

Uncommon side effects (may affect up to 1 in 100 people):

  • anxiety and depression
  • changes in blood tests which show how the liver is working
  • low blood pressure, fast or irregular heart rate
  • joint and muscle pains.

Very rare side effects (may affect up to 1 in 10,000 people):

  • low numbers of white blood cells which make infections more likely
  • serious allergic reaction which can cause dizziness, swelling of the face, lips, tongue or throat and difficulty breathing
  • generalised skin rash (nettle rash), itching
  • fainting.

Other side effects with frequency not known (frequency cannot be estimated from available data):

  • vomiting.

Some people taking Mizollen have also experienced: difficulty in breathing or wheezing, worsening of their asthma or small changes in blood sugar levels and blood salts. Your doctor may organise blood tests to monitor your progress.

Some antihistamines (anti-allergy medicines) have been associated with an abnormality in the electrical recording of the heart beat, increasing the risk of an irregular heartbeat.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store mizollen.

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 carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Refer to the storage conditions on the carton.

Do not use Mizollen if you notice that the tablets become discoloured.

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 mizollen contains- the active substance is mizolastine

  • – Each tablet contains 10mg of mizolastine

  • – The other ingredients are:

  • Core: hydrogenated castor oil, lactose monohydrate, microcrystalline cellulose, tartaric acid, povidone, anhydrous colloidal silica, magnesium stearate.
  • Film-coating: hypromellose, titanium dioxide (E171), propylene glycol.

What Mizollen looks like and contents of the pack

The tablets are oblong, white with a scored line on one side and a mark „MZI 10“ on the reverse side.

It is presented in boxes of 4, 7, 10, 15, 20, 30, 50, or 100 in Aluminium (oPA/Aluminium/PVC) blisters, in Aluminium/PVC blisters or in polypropylene tablet container with polyethylene caps.

Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi

410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Tel: 0800 035 2525

email:

Manufacturer

Sanofi Winthrop Industrie

30–36 Avenue Gustave Eiffel – 37000 Tours

France

This leaflet was last approved in 09/2020

© Sanofi, 2003 – 2020

792916

16*


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

Frequently Asked Questions

What is Mizollen 10 mg modified-release tablets used for?

Mizollen 10 mg modified-release tablets are primarily prescribed to treat anxiety and sleep disorders. They help manage symptoms by promoting relaxation.

How does Mizollen work in the body?

Mizollen works by affecting certain chemicals in the brain that may be unbalanced in people with anxiety disorders. This helps to restore mood and reduce feelings of tension.

When should I take Mizollen tablets?

It is usually recommended to take Mizollen at the same time each day, preferably in the evening or as directed by your doctor, to maintain consistent levels in your system.

Can I crush or chew Mizollen tablets?

No, you should not crush or chew Mizollen tablets as they are designed to release the medication gradually over time. Swallow them whole with water.

What should I do if I miss a dose of Mizollen?

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

What are common side effects of Mizollen?

Common side effects may include drowsiness, dizziness, dry mouth, or headache. If any side effect persists or worsens, consult your healthcare provider.

Can I drink alcohol while taking Mizollen?

It is advisable to avoid alcohol while taking Mizollen, as it can increase side effects such as drowsiness and dizziness.

Is it safe to take Mizollen during pregnancy or breastfeeding?

Consult your doctor before taking Mizollen if you are pregnant, planning to become pregnant, or breastfeeding, as safety has not been established.

How long does it take for Mizollen to start working?

Patients may begin to feel relief from symptoms within a few hours after taking Mizollen; however, it may take several days for full effects to be noticed.

Can I stop taking Mizollen suddenly?

Do not stop taking Mizollen suddenly without consulting your doctor, as this may lead to withdrawal symptoms. Your doctor will provide guidance on how to safely discontinue use.

Are there any specific foods I should avoid while taking Mizollen?

There are no specific foods that must be avoided when taking Mizollen; however, maintaining a balanced diet can support overall health and well-being.

What if I have other medical conditions while taking Mizollen?

Inform your healthcare provider about any other medical conditions you have before starting treatment with Mizollen, as they may affect dosage and safety.

Can children take Mizollen 10 mg modified-release tablets?

Mizollen is typically prescribed for adults and may not be suitable for children. Consult a pediatrician for appropriate treatment options if needed.

How should I store Mizollen tablets?

Store Mizollen tablets at room temperature in a cool, dry place away from direct sunlight and out of reach of children.

What should I do if I suspect an overdose of Mizollen?

In case of an overdose, seek immediate medical attention or contact your local poison control center for guidance on what steps to take.

Will using Mizollen affect my ability to drive or operate machinery?

Mizollen can cause drowsiness and impaired coordination; therefore, it is advised not to drive or operate heavy machinery until you know how it affects you.

Can I take other medications while on Mizollen?

Always inform your healthcare provider about any other medications you are taking before starting Mizollen, as interactions can occur.

Is there a generic version of Mizollen available?

Yes, there may be generic versions available under different brand names that contain the same active ingredient; consult your pharmacist for options.

Where can I find more information about my prescription for Mizolland?

For more information, discuss with your healthcare provider or pharmacist who can provide detailed information tailored specifically for you.