Dihydrocodeine Tablets 30mg
*
noi 1014
Read all of this 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, please 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.
What is in this leaflet:
1. What Dihydrocodeine tablets are and what are they used for
2. What you need to know before you take Dihydrocodeine tablets
3. How to take Dihydrocodeine tablets
4. Possible side effects
5. How to store Dihydrocodeine tablets
6. Contents of the pack and other information
1. What Dihydrocodeine tablets are and what are they used for
Dihydmcodeine belongs to a group of medicines called opioid analgesics.
These are strong pain killers that are used for the relief of moderate to severe pain.
2. What you need to know before you take Dihydrocodeine tablets
Do not take Dihydrocodeine Tablets if:
• you are allergic to Dihydrocodeine Tartrate, any other opioid analgescis, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of face, lips or hands/feet, or breathing difficulties.
• you suffer from severe breathing problems such as acute respiratory depression and obstructive airways disease. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected.
• you have a head injury or suffer from increased pressure on the brain (symptoms include severe headache, feeling sick)
• you often drink large amounts of alcohol
• you are at a risk of paralytic ileus (paralysis of the gut which stops the movement of food through the intestine)
• you have severe liver problems
• you are suffering from severe diarrhoea due to ulcerative colitis (ulceration and inflammation of the colon), antibiotic or food poisoning.
Dihydrocodeine should not be given to unconscious patients.
If you think any of these applies to you, do not take the tablets, talk to your doctor and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking dihydrocodeine tablets if:
• you suffer from asthma (your doctor may decide to administer Dihydrocodeine tablets if your asthma is controlled. However, you should not be given this medicine if you are having an acute asthma attack)
• you suffer from bronchitis (an inflammation of the lining of the tubes in the lungs, resulting in coughing spells accompanied by thick phlegm and breathlessness) or emphysema (a lung condition which leaves you struggling for breath)
• you are elderly or debilitated (in a weakened state)
• you have an underactive adrenal gland
• you have enlarged prostate gland (in men)
• you have difficulty passing urine
• you have low blood pressure
• you are in state of shock
• you have inflammation or blockage in the bowel (symptoms may include constipation, diarrhoea, abdominal pain/discomfort)
• you suffer from myasthenia gravis (a condition characterised by muscle weakness)
• have an underactive thyroid gland.
• you have convulsions (fits)
• you have liver or kidney problems
• you have ever been addicted to drugs
• you have problems with your bile duct
• you are taking monoamine oxidase inhibitors (MAOIs) or have been taking them within the last two weeks. MAOIs, such as phenelzine or isocarboxazid, are medicines used to treat depression.
If you think any of these applies to you, talk to your doctor or pharmacist before taking this medicine.
Other important warnings
• Do not take for longer than directed by your prescriber.
• Taking dihydmcodeine 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.
Other medicines and Dihydrocodeine tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines interact with each other and this can alter their effect. It is particularly important to tell your doctor or pharmacist if you are taking the following medicines:
monoamine oxidase inhibitors (MAOIs) used to treat depression (See “Warnings and precautions” in section 2 above)
anaesthetics (used in surgery to numb pain) hypnotics (sleeping tablets) antipsychotics (medicines used to treat mental illness)
tricyclic antidepressants (medicines used to treat depression).
anxiolytics (medicines used to treat anxiety) e.g. chlordiazepoxide and diazepam antihistamines (medicines used for allergies) medicines used for diarrhoea e.g. loperamide or kaolin
mexiletine and quinidine (used to control heart rhythm)
cisapride, metoclopramide, and domperidone (medicines that affect the passage of food) sodium oxybate (used to treat narcolepsy) cimetidine (used to treat stomach ulcers and indigestion)
Driving and using machines
Taking dihydrocodeine tablets may cause, drowsiness, confusion, blurring of vision and hallucinations. If you are affected this way do not drive or operate machinery.
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.
• 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 information provided with 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.
Dihydrocodeine Tablets with food and alcohol
The tablets should be taken after food.
Drinking alcohol during your treatment with Dihydrocodeine tablets should be avoided. Drinking alcohol during your treatment with these tablets may make you feel sleepy, and enhance hypotensive and respiratory depressive effects of alcohol.
Pregnancy and breast-feeding
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.
There have been reports of harm to the unborn child possibly with the use of similar medicine (codeine), during first three months of pregnancy.
If you take dihydrocodeine during pregnancy, your new born baby could have difficulty in breathing. If you take dihydrocodeine during pregnancy and become dependent on it, you could be sick during labour and have breathing difficulties and the new born baby may also become dependent and suffer from withdrawal symptoms.
If you are breastfeeding do not take these tablets until you have spoken to your doctor.
Your doctor will decide whether treatment with Dihydrocodeine tablets is clearly necessary or whether an alternative treatment is possible for you.
Dihydrocodeine Tablets contain lactose
This medicine contains small quantities of an inactive ingredient known as lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Dihydrocodeine tablets
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dosage is 1 tablet every four to six hours after food. The maximum daily dose is 6 tablets in 24 hours.
The dose should be reduced in elderly patients.
You may be given a reduced dose if you have kidney or liver problems. You may also be given a reduced dose if you suffer from any of the conditions listed above in the section “Talk to your doctor or pharmacist before taking Dihydrocodeine tablets if:”
Dihydrocodeine tablets are not recommended for children.
Dihydrocodeine tablets are for oral use.
The tablets should be taken after food.
Swallow them with a glass of water. Do not chew.
To help you remember to take your medicine, try to take your tablets at the same time each day.
Take your tablets as directed and for as long as directed; do not stop them, even if you feel better, as otherwise the symptoms may return.
Taking a painkiller for headaches too often or for too long can make them worse.
If you have the impression that the effect of Dihydrocodeine tablets is too strong or too weak, talk to your doctor or pharmacist.
If you take more Dihydrocodeine Tablets than you should
The maximum daily dose is 6 tablets in 24 hours. If you think you have taken too many tablets contact your doctor or nearest hospital immediately.
An overdose is likely to cause difficulty in breathing, reduction in size of pupil, and coma. Other symptoms include nausea, vomiting, fast heart rate, low blood pressure, low body temperature, confusion, fits, severe dizziness, severe drowsiness, nervousness or restlessness, hallucinations (seeing, feeling or hearing things that are not there), slow heartbeat, circulatory failure, severe weakness, abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems.
Take the remaining tablets and this leaflet with you so that the medical staff knows what you have taken.
If you forget to take Dihydrocodeine Tablets
Do not take a double dose to make up for a forgotten dose.
If you forget to take a dose then take your next dose at the usual time. Never take two doses at the same time.
If you stop taking Dihydrocodeine Tablets
Dihydrocodeine tablets can become habit forming. This is called dependence. If you stop taking your medicine suddenly it can cause symptoms such as sweating, fever, weakness and muscular pains. Your doctor will stop your tablets gradually to avoid you having these withdrawal symptoms.
If 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.
Serious side effects
If any of the following happen, stop taking Dihydrocodeine tablets and tell your doctor immediately and go to the casualty department at your nearest hospital.
• Allergic reactions; you should stop taking Dihydrocodeine tablets and see your doctor immediately if you experience symptoms such as
• swollen face, tongue or pharynx
• skin rash
• difficulty in swallowing
• hives and difficulties to breath
• pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder (biliary spasm)
• urine tube problem causing abdominal or lower back pain (ureteric spasm),
• severe pain in the stomach with bloating, gut cramps and vomiting (paralytic ileus),
• fits (especially in infants and children),
• swelling of pancreas, symptoms include severe upper stomach pain, often with nausea and vomiting (pancreatitis).
Other side effects
Tell your doctor if you notice any of the following:
• constipation, abdominal pain, stomach cramps
• feeling sick (nausea), being sick (vomiting),
• difficulty in passing urine, pain when passing urine
• headache (taking a painkiller for headaches too often or for too long can make them worse)
• sleepiness,
• itching and rash, red raised skin rash
(maculopapular rash)
• dry mouth,
• mood changes, feeling of extreme happiness
• blurred vision, double vision or other changes in vision
• sweating,
• reduced sex drive, problems with sexual performance, decreased potency,
• inability to get or keep an erection
• facial flushing (periodic attacks of redness of skin with a sensation of warmth or burning),
• low blood pressure,
• tingling in fingers and toes,
• mental depression, restlessness, confusion
• dizziness,
• drowsiness
• difficulty breathing, shortness of breath
• hallucinations and nightmares
• vertigo (dizziness characterized by spinning sensation),
• increased pressure within your head (symptoms include severe headache, feeling sick)
• narrowing of the pupils,
• irregular heart rate (palpitations), slow or fast heart beat
• dizziness when standing up quickly
• fever,
• feeling unwell, feeling tired,
• feeling cold
• an enlarged spleen or swollen/enlarged lymph nodes,
• abnormally high levels of glucose in the blood,
• loss of appetite,
• uncontrolled muscle movements.
You may become addicted or tolerant (need to take higher doses to obtain the same level of pain relief) to these tablets. Symptoms of restlessness or irritability may result when treatment is then stopped
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: 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 Tablets
- 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 label. The expiry date refers to the last day of that month.
- Keep this medicine in a dry place
- Do not store above 25°C
- Store in the original package.
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 to protect the environment.
6. Contents of the pack and other information What Dihydrocodeine tablets contain
The active substance is Dihydrocodeine Tartrate BP
The other ingredients are: Starch, Lactose, Polyvinylpyrrolidone, Sodium Starch Glycollate, Magnesium Stearate and Colloidal Anhydrous Silica.
What Dihydrocodeine tablets looks like and contents of the pack
Dihydrocodeine Tablets BP 30mg are white, circular, flat bevel edged tablets embossed with DH breakline 30 on one side and R on the reverse..
The product is available in containers of 1000,500,250, 100,90, 80, 70, 60,50,40,30, 25, 20 and 10 tablets and in blister strips of 100,90,80,70,60,50, 40,30,28,20 and 10 tablets.
Marketing authorisation holder and manufacturer:
Ranbaxy Ireland Limited Spafield, Cork Road,
Cashel, Co. Tipperary Republic of Ireland
This leaflet was last approved in Febmary 2015
LDUK014/30/B