Meptid 200mg Film-Coated Tablets

• 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. See section 4.

1. What Meptid Tablets are and what they are used for
2. What you need to know before you take Meptid Tablets
3. How to take Meptid Tablets
4. Possible side effects
5 How to store Meptid Tablets
6. Contents of the pack and other information

This medicine contains meptazinol which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

• are allergic to meptazinol or any of the other ingredients of this medicine (listed in Section 6)
• 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

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Meptid to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

• 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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

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

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.

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

If you take Meptid during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Meptid while you are breastfeeding as meptazinol passes into breast milk and will affect your baby.

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

Meptid Tablets contain the colouring agent sunset yellow FCF (E 110), which may cause allergic reactions.

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.

Meptid Tablets are not recommended for use in children.

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 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.

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

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

United Kingdom

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Ireland

• 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 (E 127), titanium dioxide (E 171) and sunset yellow (E 110) (see end of Section 2).

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.

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