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Dihydrocodeine Tablets 30mg

Document: leaflet MAH GENERIC_PL 40147-0022 change

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PACKAGE LEAFLET: INFORMATION FORTHE USER


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nogen Pharma


Dihydrocodeine 30mg Tablets


fcead all ofthis 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 or nurse.

I* 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 I as yours.

L If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

^hat is in this leaflet:

1. What Dihydrocodeine 30mg Tablets are and what they are used for . What you need to know before you take Dihydrocodeine 30mg Tablets

3.    How to take Dihydrocodeine 30mg Tablets

4.    Possible side effects

|5. How to store Dihydrocodeine 30mg Tablets 6. Contents of the pack and other information


1. WHAT DIHYDROCODEINE 30MG TABLETS ARE AND WHAT THEY ARE USED FOR


bihydrocodeine 30mg Tablets contain a medicine palled Dihydrocodeine. This belongs to a group of medicines called analgesics (pain-killers).

bihydrocodeine 30mg Tablets are used for [moderate to severe pain relief.


2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIHYDROCODEINE 30MG TABLETS


•    Do not take for longer than directed by your I prescriber

m Taking Dihydrocodeine 30mg Tablets regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets |* Taking a painkiller for headaches too often or for too long can make them worse.

Do not take Dihydrocodeine 30mg Tablets if:

l You are allergic (hypersensitive) to I dihydrocodeine, codeine or any of the other ' ingredients of this medicine (listed in section 6) |* You have breathing difficulties

•    You suffer with obstructive airways disease

|* Your doctor has told you that you are at risk of, or have, bowel paralysis (paralytic ileus)

|* You are alcohol dependent

•    You have a head injury or a condition where there is increased pressure in the skull (may cause painful eyes, change in vision or headache behind the eyes).

arnings and precautions:

[Talk to your doctor, or pharmacist or nurse before taking Dihydrocodeine 30mg Tablets if:

|* You suffer with asthma

•    You have low blood pressure or are in shock

I* You are a man with an enlarged prostate gland (prostatic hypertrophy) and have difficulty urinating

   You have epilepsy or any other convulsive ' disorder

b You have liver disease

•    You have kidney problems

|* You suffer with hypothyroidism (reduced activity of the thyroid gland)


•    You have taken a monoamine-oxidase inhibitor (a medicine for depression e.g. phenelzine or tranylcypromine) in the last two weeks

•    You are weak due to illness

•    You have adrenal gland insufficiency (symptoms include low blood pressure, low blood sugar, muscle weakness, nausea, vomiting, dizziness, skin discolouration, weight loss)

•    You have inflammation or blockage in the bowel (symptoms may include constipation, diarrhoea, abdominal pain/discomfort).

If you are elderly the dose of this medicine may be reduced by your doctor.

Other medicines and Dihydrocodeine 30mg Tablets:

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

In particular:

•    Medicines for correcting abnormal heartbeat e.g. mexiletine

•    Antipsychotic medicines used to treat mental disorders e.g. chlorpromazine, haloperidol or sulpiride

•    Hypnotic and sedative medicines used for short-term treatment of sleeplessness or psychiatric illness, or to calm you down e.g. diazepam or nitrazepam

•    Medicines used to treat HIV infections e.g. ritonavir

•    Medicines used to treat nausea (feeling sick) and vertigo (spinning sensation when not moving) e.g. metoclopramide, cyclizine or domperidone

•    Medicines used to treat stomach ulcers e.g. cimetidine

•    A type of anti-depressant medicines called monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine and tranylcypromine, used to treat depressive illness

•    Other medicines used to treat depression (tricyclic antidepressants such as amitriptyline)

•    Medicines used in anaesthesia (this is important if you have recently or are about to receive treatment where an anaesthetic may be used)

•    Medicines used to treat allergies (antihistamines).

You should not drink alcohol while you are taking Dihydrocodeine 30mg Tablets.

Pregnancy and breastfeeding:

Please tell your doctor or pharmacist before you take this medicine if you are pregnant, thinking of becoming pregnant or are breast feeding. Do not take Dihydrocodeine Tablets during late pregnancy orwhilst breast-feeding, unless advised by your doctor.

Driving and using machines:

Using Dihydrocodeine 30mg Tablets may affect your ability to drive or operate machinery. Effects such as 'pins and needles', dizziness, spinning sensations, muscle rigidity, visual disturbances, drowsiness, confusion or hallucinations may occur. You should not drive or operate machinery if affected.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

•    Do not drive while taking this medicine until you know how it affects you


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f It is an offence to drive if this medicine affects I 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 provided with the medicine and L 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.

iDihydrocodeine 30mg Tablets contain lactose:

These tablets contain lactose. If you have been |told by your doctor that you have an intolerance to some sugars, tell your doctor or pharmacist before Itaking this medicine.


•    Eyes - blurred or double vision,    i

extremely small pupils

•    Psychiatric effects - drowsiness,    |

changes ofmood, confusion, sexual dysfunction, hallucinations (seeing or | hearing things that are not real), excitation    I

•    Heart - slow or fast heart rate,

palpitations, low blood pressure    I

•    Urinary system - pain and difficulty inpassing urine and less frequent to do so

•    Other - water retention (oedema).



3. HOW TO TAKE DIHYDROCODEINE 30MG TABLETS


Always take Dihydrocodeine 30mg Tablets exactly as your doctor has instructed you. You should pheck with your doctor or pharmacist if you are unsure.

Dihydrocodeine 30mg Tablets should be swallowed kith water after a meal.

kdults and children over 12 years of age:

Usual dose: one tablet (30mg) every 4to6 hours, when necessary.

jElderly patients may be given lower doses. 'Maximum dose in 24 hours is 180mg (6 tablets).

Children under 12 years ofage:

|Not suitable for children under 12 years of age.

Ilfyou take more Dihydrocodeine 30mg Tablets than you should:

This medicine is to be taken at regular intervals, as determined by your doctor. If you take too many tablets by mistake contact your nearest hospital pasualty department, or tell your doctor immediately. Take your tablet pack with you.

It is important that you take your tablets as stated bn the pharmacist's label or as advised by your doctor. You should use only as much as your doctor recommends.

l|fyou stop taking Dihydrocodeine 30mg Tablets:

Do not stop taking Dihydrocodeine 30mg Tablets ^ithout consulting your doctor first as your condition may deteriorate.

Ifyou forget to take Dihydrocodeine 30mg tablets:

.Ifyou have forgotten to take your medicine, this should not be a problem. Take the missed dose as soon as you remember if needed for the relief of symptoms. If not needed, do not take the missed pose and go back to your normal dose schedule. If you have trouble remembering when to take your |medicine, tell your doctor or pharmacist.


Side effects are more common when taking a dose greater than 30mg a day.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.


5. HOW TO STORE DIHYDROCODEINE 30MG TABLETS


Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.

Do not store above 25°C and protect from light. Store in the original package.

In case of any visible signs of deterioration, you should discard the package.

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

Keep out of the sight and reach of children


6. CONTENTS OF THE PACK AND OTHER INFORMATION


4. POSSIBLE SIDE EFFECTS


Like all medicines, this medicine can cause side pffects, although not everyone gets them.

^Ilergic reactions may occur rarely. Symptoms can include skin rashes, itching, swelling ofthe face, pyes or throat and difficulty with breathing. If any of these occur STOP taking these tablets immediately pnd contact your doctor.

bell your doctor if you notice any of the following side effects or notice any other effects not listed: l Gastrointestinal system - constipation, feeling i or being sick, abdominal pain, dry mouth • Nervous system - 'spinning' sensation, dizziness, headache, 'pins and needles', slow and shallow breathing, muscle rigidity |* Skin - rash, itchy skin, irregular raised patches, flushed face


What Dihydrocodeine 30mg Tablets contain:

Each tablet contains 30mg of Dihydrocodeine.

The other ingredients are: maize starch, polyvinylpyrrolidone, lactose, sodium starch glycollate, magnesium stearate and colloidal silicon dioxide.

What Dihydrocodeine 30mg Tablets look like and contents of the pack:

The tablets are round, white coloured tablets with a flat bevel-edge, with 30 on one side and plain on the other side.

The tablets are available in securitainers with pack sizes: 25, 50, 100, 250, 500, 1000.

Marketing Authorisation Holder

Ennogen Pharma Limited,

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Clonmel Healthcare Limited Waterford Road, Clonmel, Co Tipperary Republic of Ireland

This leaflet was last revised in March 2016.


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