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Meptid Tablets 200mg

ANVERSO    Sentido de lecture 40 mm

- min

PACKAGE LEAFLET: INFORMATION FOR THE USER

Meptid* 200 mg Film-Coated Tablets

Meptazinol

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Meptid Tablets are and what they are used for

2.    Before you take Meptid Tablets

3.    How to take Meptid Tablets

4.    Possible side effects

5 How to store Meptid Tablets 6. Further information

1 .WHAT MEPTID TABLETS ARE AND WHAT THEY ARE USED FOR

The name of this medicine is Meptid 200 mg Film-Coated Tablets but will be referred to as Meptid Tablets throughout the remainder of the leaflet.

Meptid Tablets belong to a group of medicines known as opioid analgesics, which are used to relieve pain. They contain meptazinol as the active ingredient.

Meptid Tablets are used for the short-term treatment of moderate pain from a variety of causes.

2. BEFORE YOU TAKE MEPTID TABLETS

Do not take Meptid Tablets if you

•    are allergic (hypersensitive) to meptazinol or any of the other ingredients of Meptid Tablets (see Section 6 ‘Further information')

   have any alcohol-related problems

•    have or you are at risk of getting paralysis of the gut (intestine) known as paralytic ileus

•    have a head injury, or build-up of pressure in the head (raised intracranial pressure)

•    are having problems breathing

•    are having an asthma attack

•    are taking medicines known as monoamine-oxidase inhibitors (MAOIs) or have stopped taking MAOIs less than 14 days ago

Take special care with Meptid Tablets if you

•    have any liver or kidney problems

•    have any severe breathing problems such as asthma (do not take this medicine during an asthma attack)

•    have low blood pressure

•    have an under-active thyroid gland (hypothyroidism)

•    have an enlarged prostate gland

•    suffer from fits or seizures (convulsive disorder)

•    think your pain is due to a heart attack.

If any of these apply to you, tell your doctor or pharmacist before you take Meptid Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking any medicines known as monoamine-oxidase inhibitors (MAOIs) including moclobemide to treat, for example, depression, or if you have taken this type of medicine during the past two weeks, you should also talk to your doctor.

In particular, tell your doctor if you are taking, or have recently taken, any of the following medicines which are known to interact with Meptid Tablets:

•    medicines for treatment of depression known as monoamine-oxidase inhibitors (MAOIs) including moclobemide, and those called tricyclic antidepressants such as amitriptyline or mirtazapine

•    medicines for certain mental disorders, such as chlorpromazine

•    ritonavir (for HIV infection)

•    ciprofloxacin (for bacterial infections)

•    domperidone and metoclopramide (for nausea and vomiting)

•    cimetidine (for ulcers)

•    anti-anxiety and sleeping medicines such as diazepam and nitrazepam

Taking Meptid Tablets with food and drink

Avoid taking alcohol with this medicine as it may make you feel especially dizzy and sleepy.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should not take Meptid Tablets during pregnancy or while breast-feeding unless your doctor thinks that it is essential.

Driving and using machines

If this product makes you dizzy or drowsy, you should not drive or operate machinery.

Important information about some of the ingredients of Meptid Tablets

Meptid Tablets contain the colouring agent sunset yellow FCF (E110), which may cause allergic reactions in some people.

3. HOW TO TAKE MEPTID TABLETS

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

REVERSO


The usual dose is Adults and elderly patients:

Swallow one tablet, with a glass of water, every four hours; your doctor may vary the dose if necessary.

If you have the impression that the effect of Meptid Tablets is too strong or too weak, talk to your doctor or pharmacist. Do not take more than your doctor has recommended. Long term use of Meptid Tablets may cause dependence and tolerance. If you are worried about this, talk to your doctor or pharmacist. Meptid Tablets are usually only used for short-term treatment of pain. Children:

Meptid Tablets are not recommended for use in children. If you take more Meptid Tablets than you should If you think you have taken too many tablets contact your doctor or the local hospital casualty department at once.

Take any remaining tablets and the packaging with you.

If you forget to take Meptid Tablets

If you forget to take a dose at the right time, take it as soon as you remember, unless it is almost time for your next dose. If you miss a dose completely, do not take a double dose to make up for the forgotten one. Instead, skip the missed one and take the next dose as usual.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Meptid Tablets can cause side effects, although not everybody gets them.

If you experience any of the following, stop taking Meptid Tablets and contact your doctor or go to the casualty department of your nearest hospital immediately:

•    Severe Allergic reactions. Signs of an allergic reaction include itching, rash, difficulty breathing, swelling of the face, lips, tongue or throat.

At the correct dose Meptid Tablets should not generally cause any problems.

The most commonly reported side effects are:

•    feeling or being sick

•    constipation or diarrhoea

•    stomach pains, indigestion

•    dizziness and vertigo

•    drowsiness and sleepiness

•    sweating

•    headache

•    rash.

Occasionally the following side effects have been reported, which may have been due to Meptid Tablets:

•    confusion

•    depression

•    hallucinations

•    low blood pressure

•    breathing problems.

Other side effects that have not been mentioned above, but are associated with medicines that act in the same way as Meptid Tablets include:

•    difficulty in passing urine

•    dry mouth

•    red face

•    unusually fast or slow heart beat, palpitations

•    feeling unusually cold

•    mood changes


•    reduction in pupil size

•    depression or anxiety (dysphoria)

•    abdominal pain as a result of spasms of the bile duct or ureter

•    decreased sexual desire, erectile dysfunction

•    hives, rash, itching.

Reporting of side effects

If you 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 (see below):

United Kingdom

Yellow Card Scheme, Website:

www.mhra.aov.ukA/ellowcard

Ireland

HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2,

Tel: +353 1 6764971, Fax: +353 1 6762517,

Website: www.hpra.ie. e-mail: medsafety@hpra.ie By reporting side effects you can also provide more information on the safety of this medicine.

5.    HOW TO STORE Meptid Tablets

Keep out of the reach and sight of children.

Do not use Meptid Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION

What Meptid Tablets contain

The active substance is meptazinol. Each tablet contains 200 mg of meptazinol (as hydrochloride).

•    The other ingredients are magnesium stearate, microcrystalline cellulose and polacrilin potassium in the tablet core. The film coating contains hypromellose, macrogol 400 and the colours erythrosine (E127), titanium dioxide (E171) and sunset yellow (E110) (see end of Section 2).

What Meptid Tablets look like and contents of the pack Meptid Tablets are film-coated tablets and orange and oval shaped. The film-coated tablets are engraved with ‘MPL 023’ on one side and are available in blister packs of 6,28,56,100 or 112 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder:

Almirall S.A.,

Ronda General Mitre 151,

08022 Barcelona, Spain Manufacturer:

Kern Pharma SL,

Poligono Ind. Colon II, Venus 72,

E-08228, Terrassa, Spain.

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This leaflet was last written in June 2015    3

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