CO-CODAMOL 8 MG / 500 MG EFFERVESCENT TABLETS, ZIPAMOL PLUS 8 MG / 500 MG EFFERVESCENT TABLETS - patient leaflet, side effects, dosage

Zipamo!

PLUS 8 mg/500 mg effervescent tablets codeine phosphate hemihydrate and paracetamol

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

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

Important things you should know about Zipamol PLUS 8 mg/500 mg effervescent tablets

• This medicine can only be used for the short term treatment of acute, moderate pain such as headaches, migraine, neuralgia, toothache, painful menstrual periods and rheumatic pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
• You should only take this product for a maximum of three days at a time. If you need to take it for longer than three days you should see your doctor or pharmacist for advice.
• If you take this medicine for headaches for more than three days it can make them worse.
• The name of your medicine is Zipamol PLUS 8 mg/500 mg effervescent tablets (called Zipamol PLUS throughout this leaflet).
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Zipamol PLUS is and what it is used for

• 2. What you need to know before you take Zipamol PLUS

• 3. How to take Zipamol PLUS

• 4. Possible side effects

• 5. How to store Zipamol PLUS

• 6. Contents of the pack and other information

1.What Zipamol PLUS is and what it is used for

Zipamol PLUS contains codeine phosphate and paracetamol. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. Zipamol PLUS is used in adults and children over 12 years of age for the short term treatment of acute moderate pain caused by headaches, migraine, toothache, neuralgia, period pain and rheumatic pains when other painkillers such as paracetamol, ibuprofen or aspirin alone have not worked. Wait at least 4 hours after you last took other painkillers before taking this medicine.

2.What you need to know before you take Zipamol PLUS

• This medicine contains codeine which can cause addiction if you take it continuously for more than three days. This can give you withdrawal symptoms from the medicine when you stop taking it
• This medicine contains paracetamol. Do not take anything else containing paracetamol while taking this medicine
• If you take a painkiller for headaches for more than three days it can make them worse

Warnings and precautions

Talk to your doctor before taking Zipamol PLUS 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 Zipamol PLUS 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 doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Do not take Zipamol PLUS and tell your doctor if:

• You are allergic (hypersensitive) to codeine, paracetamol or any of the other ingredients in your medicine (listed in Section 6). Signs of an allergic reaction include a rash and breathing problems. There can also be swelling of the legs, arms, face, throat or tongue
• You are taking medicines to treat depression called MAOIs (Monoamine Oxidase Inhibitors) or have taken them in the last 14 days. MAOIs are medicines such as moclobemide, phenelzine, tranylcypromine
• The person going to take the tablets is under 12 years of age. Zipamol PLUS must not be given to children under 12 years of age
• You are under 18 years of age and have had your tonsils or adenoids removed due to obstructive sleep apnoea syndrome
• You know that you metabolise very rapidly codeine into morphine
• You are breast-feeding or planning to breast-feed.

Do not take Zipamol PLUS if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Zipamol PLUS.

Take special care and check with your doctor before taking Zipamol PLUS if:

• You have severe kidney or liver problems
• You have a liver problem caused by alcohol
• You are taking a benzodiazepine
• You suffer from seizures.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.

Codeine is transformed to morphine in the liver by an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this enzyme and this can affect people in different ways. In some people, morphine is not produced or produced in very small quantities, and it will not provide enough pain relief. Other people are more likely to get serious side effects because a very high amount of morphine is produced. If you notice any of the following side effects, you must stop taking this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite.

Children and adolescents over 12 years of age Use in children and adolescents after surgery Zipamol PLUS should not be used for pain relief in children and adolescents after removal oftheir tonsils or adenoids due to Obstructive Sleep Apnoea Syndrome.

Use in children with breathing problems

Zipamol PLUS is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children. Zipamol PLUS is not recommended in adolescents over 12 years-old with breathing problems.

Other medicines and Zipamol PLUS

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Zipamol PLUS can affect the way some other medicnes work or other medicines can affect the way Zipamol PLUS works.

Zipamol PLUS contains paracetamol. Do not take anything else containing paracetamol while taking this medicine.

This includes some painkillers, cough and cold remedies. It also includes a wide range of other medicines available from your doctor and more widely in shops.

Tell your doctor or pharmacist if you are taking any of the following medicines, or have taken them in the past 14 days:

• Medicines which make you drowsy or sleepy (CNS depressants or a benzodiazepine) such as sleeping tablets, sedatives, tranquilisers, hypnotics and medicines used to treat anxiety or anaesthetics
• Anti-depressant medicines such as imipramine, amitriptyline, tranylcypromine, dosulepin, mirtazapine or chlorpromazine.

Tell your doctor or pharmacist if you are taking any other medicines:

• Medicines used to thin the blood such as warfarin
• Chloramphenicol – an antibiotic used for infections
• Metoclopramide or domperidone – used to stop you feeling sick (nausea) or being sick (vomiting)
• Colestyramine – for lowering blood cholesterol levels
• The oral contraceptive pill.

Ifyou are not sure if any ofthe above applies to you, talk to your doctor or pharmacist before taking Zipamol PLUS.

Pregnancy and breast-feeding

Do not take Zipamol PLUS if you are pregnant, breastfeeding or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby.

Ifyou use Zipamol PLUS during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Zipamol PLUS while you are breast-feeding as codeine passes into breast milk and will affect your baby.

Driving and using machines

Zipamol PLUS can affect your ability to drive as it may make you sleepy or dizzy.

• Do not drive whilst taking this medicine until you know how it affects you
• It is an offence to drive if this medicine affects your ability to drive
• However, you would not be committing an offence if:

• – The medicine has been prescribed to treat a medical or dental problem and – you have taken it according to the instructions given by the prescriber or in the medicine and

• – it was not affecting your ability to drive safely.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Zipamol PLUS contains sodium and sorbitol

• Sodium: This medicinal product contains 418.59mg sodium (main component of cooking/table salt) per tablet, equivalent to 20.93% of the WHO recommended maximum daily intake of sodium for an adult.

The maximum daily dose of this product is equivalent to 167.44% of the WHO recommended maximum daily intake for sodium.

Zipamol PLUS is considered high in sodium. This should be particularly taken into account for those on a low sodium diet.

• Sorbitol (E 420): This medicine contains 100mg sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3.how to take zipamol plus

Always take Zipamol PLUS exactly as instructed in this leaflet. Check with your doctor or pharmacist if you are not sure.

• Do not take for more than three days. If you need to use this medicine for more than three days you should speak to your doctor or pharmacist
• This medicine contains codeine and can cause addiction if you take it continuously for more than three days. When you stop taking it you may get withdrawal symptoms. You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms
• Do not take more than the recommended dose.
• Dissolve the effervescent tablets in a glass of water before taking.

Adults over 18 years of age and the elderly: 2 tablets every 4 to 6 hours when necessary up to a maximum of 8 tablets in 24 hours.

Children aged 16 to 18 years: 1 to 2 tablets every 6 hours when necessary up to a maximum of 4 doses in 24 hours.

Children aged 12 to 15 years: 1 tablet every 6 hours when necessary to a maximum of 4 doses in 24 hours.

Children under 12 years: Zipamol PLUS should not be given to children below the age of 12 years of age due to the risk of severe breathing problems.

This medicine should not be taken for more than 3 days. If the pain does not improve after 3 days, talk to your doctor for advice.

There is a risk that you may become addicted to or dependent on these tablets (a need to keep taking the medicines). If you take these for a long time you can become used to the effects and you may need to take higher doses to control your pain.

If you take more Zipamol PLUS than you should

• Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage
• Remember to take any remaining tablets and the pack with you. This is so the doctor knows what you have taken.

If you forget to take Zipamol PLUS

If you forget to take a dose at the right time, take it as soon as you remember. However do not take a double dose to make up for a forgotten dose.

Remember to leave at least 4 hours between doses.

If you stop taking Zipamol PLUS

This medicine contains codeine and can cause addiction if you take it continuously for more than 3 days. When you stop taking it you may get withdrawal symptoms.

You should talk to your doctor or pharmacist if you think you are suffering from withdrawal symptoms.

4.possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may have side-effects when taking this medicine. The following side effects may happen with this medicine:

Important side effects you should know about Zipamol PLUS

• Taking a painkiller for headaches too often or for too long can make them worse
• Drug Withdrawal

i When you stop taking Zipamol PLUS, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.

Stop taking Zipamol PLUS and see a doctor or go to a hospital straight away if:

• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are having an allergic reaction to Zipamol PLUS.
• You get serious skin reactions. Very rare cases have been reported.
• You have a fit (seizure).
• You have difficulty breathing and you feel dizzy.

Talk to your doctor straight away if you notice the following serious side effect

• Severe stomach pain, which may reach through to your back. This could be a sign of inflammation of the pancreas (pancreatitis). This is a very rare side effect.

Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

• Constipation
• Feeling sick (nausea), being sick (vomiting), dry mouth
• Dizziness, light-headedness, drowsiness, confusion
• Feeling overly happy (euphoria)
• A feeling of unease or dissatisfaction
• Excessive constriction (shrinking) of pupil of your eye
• Difficulty in passing water (urine)
• Becoming dependent on codeine
• You get infections or bruise more easily than usual. This could be because of a blood problem (such as agranulocytosis, neutropenia or thrombocytopenia).

How do I know if I am addicted?

If you notice any of the following signs whilst taking Zipamol PLUS, it could be a sign that you have become addicted.

• You need to take the medicine for longer than advised by your prescriber
• You feel you need to use more than the recommended dose
• You are using the medicine for reasons other than prescribed
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

5.how to store zipamol plus

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the pack. The expiry date refers to the last day of that month.

Do not store above 25°C.

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

Ask your pharmacist how to dispose of medicines no longer required. Do not dispose of medicines by flushing down a toilet or sink or by throwing away with your normal household rubbish. These measures will help protect the environment.

6.contents of the pack and other information

What Zipamol PLUS contains

The active substances of Zipamol PLUS 8 mg/500 mg effervescent tablets are codeine phosphate hemihydrate and paracetamol. Each tablet contains 8 mg of codeine phosphate and 500 mg of paracetamol.

The other ingredients are citric acid, anhydrous, sorbitol (E420), sodium hydrogen carbonate, povidone, simeticone, sodium carbonate anhydrous, saccharin sodium, macrogol 6000.

What Zipamol PLUS 8 mg/500 mg Effervescent Tablets look like and contents of pack

Zipamol PLUS 8 mg/500 mg effervescent tablets are white to off-white, round, flat, bevelled edge tablets, plain on both sides. The diameter of tablet is approximately 25.4 mm.

They come in Surlyn strip packs containing 32 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Accord, Barnstaple, EX32 8NS, UK

Manufacturer:

Accord Healthcare Limited,

Sage house, 319 Pinner road,

Harrow, HA1 4HF,

United Kingdom

This leaflet was last revised in May 2021

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