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CO-CODAMOL TBL 500/8MG N20

Attention: Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for treating a health problem or disease, or prescribing any medication. iDrugs24.com is not responsible for any damage to your health as the result of self treatment.

# On 2024-Mar-29
CO-CODAMOL-drug/medicine -tablets aproximate price on "CO-CODAMOL TBL 500/8MG N20" in Riga city, Latvia is:
  • 2.89€  3.12$  2.47£  334Rub  33.3SEK  12PLN  11.5₪ 

CO-CODAMOL TBL 500/8MG N20


Maximum allowed state defined price ( from ZVA webpage) Euro:State defined maximum allowed price indicated on the picture on drug/medicine -tablets  CO-CODAMOL TBL 500/8MG N20     Recheck

ATC codeN02AJ06 

 


Vendor, principal: Actavis Ltd
No prescription needed/Patient care products, dressings, gloves, medical devices,...

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CO-CODAMOL TBL 500MG+8MG N20, Paratsetamool, Kodeiin Rx
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Co-Codamol tab.obd.30mg/500mg N30, Codeini Phosphas Hemihydricus, Paracetamolum Rx (Actavis Nordic A/s) [Bulgaria]
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CO-CODAMOL 30MG/500MG N30 Rx (Sicor)
10.94€, Feb.2024 Internet pharmacy Latvija internetaptieka.lv T. 26699176, Address: Riga, Dzelzavas street 120M, LV-1021. Opening hours: Working days: 9.00-18.00. Prescription medicines can be received in person with a prescription or identity document, or ordered with delivery, if an e-prescription has been issued.Real final price may be varied.
* This table was compiled fully automatically, independently from any advertisers, transparently and without any modification relaying the open offers available on the mentioned dates.
 .

CO-CODAMOL 500MG/+8MG N20

Package leaflet: information for the user

Co-codamol, 500 mg/ 8 mg tablets

Paracetamol and codeine phosphate hemihydrate

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse in 3 days.

What is in this leaflet:

1.   What Co-codamol is and what it is used for
2.   What you need to know before you use Co-codamol
3.   How to use Co-codamol
4.   Possible side effects
5.   How to store Co-codamol
6.   Contents of the pack and other information

1.   What Co-codamol is and what it is used for

The active substances of Co-codamol belong to a group of medicines called analgesics. Co-codamol tablets are indicated for moderate pain (suitable for e.g. headache, neuralgia, toothache, rheumatic pain and menstrual pain).
Codeine is indicated for the treatment of acute moderate pain in children aged 12 years and above and adults, only if the pain is not treatable with other analgesics such as paracetamol or ibuprofen.

2.   What you need to know before you use Co-codamol Do not take Co-codamol:

-   if you are allergic to paracetamol, codeine phosphate, other opiates or any of the other ingredient(s) of this medicine (listed in section 6);
-   if you have diarrhoea, caused by intoxication or use of antibiotics;
-   if you have trouble breathing or you suffer from chronic lung disease;
-   if you suffer from asthma or an allergy-related disease;
-   if you suffer from liver disease or adrenal disease (Addison’s disease or pheochromocytoma);
-   if you suffer from inflammatory bowel disease (ulcerative colitis, Crohn's disease), gallbladder disease, or gallstones (cholelithiasis);
-   if you have recently had digestive tract or urinary tract surgery;
-   if you are male and you experience difficulty with urination;
-   if you have epilepsy or have had a head injury;
-   if you have hypothyroidism;
-   if you have myasthenia gravis;
-   if your blood pressure is low or you have lost much fluid (shock);
-   if you have had or now have problems with alcohol abuse, drug dependence, suicidal thoughts or suicide attempts, if you have suffered from a mental illness, of if you use narcotics - all of these factors contribute to the formation of drug dependence;
-   if you are an elderly patient or a patient with poor health;
-   if you use other paracetamol-containing medications;
-   in children (under 18 years) who have had tonsils or adenoids removed due to obstructive sleep apnoea syndrome. These patients are at higher risk of developing serious and life-threatening side effects;
-   breast-feeding mothers, because codeine is excreted into breast milk and may thereby enter the child's body;
-   for pain relief in patients who are known to metabolise very rapidly, because they are at a higher risk of developing serious side effects of codeine.

Warnings and precautions

Talk to your doctor before using Co-codamol:
-   if you plan to undertake a scheduled surgery, including dental extraction, of if you plan to take a blood or urine test, do inform your doctor or dentist about the medications you are taking;
-   if you have Gilbert's syndrome (familial hyperbilirubinaemia);
-   if you have glucose-6-phosphate dehydrogenase deficiency;
-   if you have impaired renal function;
-   if you have nutrition disorders (hyponutrition, anorexia nervosa);
-   if you abuse alcohol.
If you administer analgesics every two days or more often during a longer period (>3 months), you may develop a headache, or your headache may worsen. Headache caused by drug overuse should not be treated by further increasing of the dosage. In such cases, please consult your doctor.
Sudden discontinuation of long-term and high-dosage use of improper analgesics may cause headaches, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms will pass in a few days. Until then the administration of analgesics should be avoided and not resumed before consulting a doctor.

Other medicines and Co-codamol

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
It is of the utmost importance to tell your doctor if you use the following medications:
-   antibiotics (e.g. ciprofloxacin);
-   diuretics (e.g. spironolactone, furosemide, acetazolamide);
-   anticoagulants (e.g. warfarin);
-   antihypertensives (e.g. guanethidine);
-   antidiarrhoeal medications (e.g. loperamide, kaolin); epilepsy medicines (e.g. phenytoin carbamazepine, sodium valproate);
-   anticholinergics (atropine, hyoscine);
-   nervous system inhibitors (sleeping pills, diazepam, hydroxyzine and psychiatric medications);
-   antidepressants (e.g. tranylcypromine, amitriptyline);
-   medications that affect liver enzymes (e.g. primidone and rifampicin);
-   barbiturates;
-   opioid antagonists (e.g. buprenorphine, naloxone, naltrexone);
-   monoamine oxidase (MAO) inhibitors (certain antidepressants, e.g. moclobemide);
-   oral contraceptives (birth control pills);
-   cyclizine;
-   mexiletine;
-   selegiline;
-   cimetidine;
-   cisapride;
-   metoclopramide;
-   domperidone;
-   cholestyramine;
-   chloramphenicol;
-   alcohol.
If you refer to another hospital or another doctor, please inform the doctors about the medications you are using.

Co-codamol with food, drink and alcohol

If your everyday diet is not nutritious enough or does not contain enough protein, more interactions may occur while using Co-codamol tablets.
Consumption of alcohol is NOT ALLOWED while using Co-codamol. If you have any further questions, ask your doctor.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy: Regular use during pregnancy may cause physical dependence in the foetus and withdrawal symptoms after birth. When opiates are used during delivery, the opiates reach foetal circulation and may cause respiratory depression in neonates. Co-codamol should not be used during the first trimester of pregnancy. The use of Co-codamol should be avoided during delivery.
Breast-feeding: Do not use this or other codeine containing medications during the lactation period, unless you have your doctor’s permission. Codeine is excreted into breast milk and may harm the baby. However, if the doctor has prescribed the medication during the lactation period, the dosage should be as low as possible. The infant should be carefully observed for signs and symptoms of toxicity, like excessive somnolence, suckling difficulties, breathing difficulties and cataplexy (decrease of muscle tone). If the infant develops such symptoms, you must refer to the doctor immediately.

Driving and using machines

Co-codamol tablets may cause drowsiness and dizziness; should this happen, do not drive a car or use machines.

3. How to use Co-codamol

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Recommended doses:
Adults and adolescents over 15years: 1-2 tablets, re-administer every 4-6 hours if necessary. Do not take more than 8 tablets in 24 hours.
Children aged 12-15: 1 tablet every 6 hours. Do not give your child more than 4 tablets in 24 hours.
Codeine should not be used in children under 12 years of age as there is a risk of opiate poisoning due to the unstable and unpredictable metabolism of codeine and morphine.
Postoperative use
Co-codamol should not be used in children (under 18 years) who have had tonsils or adenoids removed due to obstructive sleep apnoea syndrome. These patients are at higher risk of developing serious and life-threatening side effects.
Use in children with respiratory difficulties
Codeine should not be used in children with respiratory difficulties.
Patients with impaired hepatic function: the medication should be used with caution (lower the dose, if necessary). This medication should not be used in case of severe hepatic impairment.
Patients with impaired renal function: the medication should be used with caution. The dosage in patients with impaired renal function should be brought down to a minimum and the patients should be carefully observed.
The tablets should be taken with liquid. If your symptoms remain for more than 3 days, please consult your doctor.
If you feel that the effect of the Co-codamol is too strong or too weak, talk to your doctor or pharmacist.

If you take more Co-codamol than you should

If you have accidentally taken too high dose and even if you feel well, refer to the nearest hospital or contact your doctor immediately. Overdose may cause severe liver damage. Take the rest of the tablets and the package with you.

If you forget to take Co-codamol

If you forget to take the medication, take it as soon as possible. Take the next dose as scheduled. NEVER take two doses at once. Ask your doctor of pharmacist for advice.
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.
The most common side effects of Co-codamol are tiredness, nausea and constipation, occurring in 1-10% of the users.
Approximately 15% of the users experience adverse reactions caused mainly by the pharmacological effects of codeine.
Blood and lymphatic system disorders
Rare (>1/10,000 to <1/1,000)
Thrombocytopenia (low blood platelet count), haemolytic anaemia (breakdown of red blood cells), agranylocytosis (decrease in the number of granulocytes - a type of white blood cells), leukopenia (decrease in the number of white blood cells - leukocytes), platelet disorders, stem cell disorders, neutropenia (decrease in the number of neutrophils - a type of white blood cell).
Very rare (<1/10,000)
Anaemia.
Metabolism and nutrition disorders
Very rare (<1/10,000)
Hypoglycaemia (low blood sugar).
Nervous system disorders
Common (>1/100 to <1/10)
Drowsiness, headache.
Uncommon (>1/1,000 to <1/100)
Dizziness.
Rare (>1/10,000 to <1/1,000)
Hand tremors.
Not known (cannot be estimated from the available data)
Syncope (in case of high dosages).
Eye disorders
Uncommon (>1/1,000 to <1/100)
Vision disorders (in case of high doses).
Ear and labyrinth disorders
Rare (>1/10,000 to <1/1,000)
Tinnitus (noises or ringing in the ears).
Thoracic and mediastinal disorders:
Uncommon (>1/1,000 to <1/100)
Respiratory depression (in patients with increased intracranial pressure or head injury).
Rare (>1/10,000 to <1/1,000)
Breathlessness.
Very rare (<1/10,000)
Bronchospasm.
Gastrointestinal disorders
Common (>1/100 to <1/10)
Nausea, constipation, vomiting.
Uncommon (>1/1,000 to <1/100)
Dry mouth.
Rare (>n 1/10,000 to <1/1,000)
Gastric pain, bleeding.
Renal and urinary disorders
Very rare (<1/10,000)
Renal impairment (may occur in case of long-term use, see Section 4.4), cloudy urine, renal side effects
Skin and subcutaneous tissue disorders
Rare (>1/10,000 to <1/1,000)
Skin rash, urticaria, itching (pruritus), redness.
Vascular disorders
Common (>1/100 to <1/10)
Sweating.
General and injection site reactions
Common (≥1/100 to <1/10)
Weakness.
Rare 01/10,000 to <1/1,000)
High fever, drowsiness.
Immune system disorders
Rare 01/10,000 to <1/1,000)
Allergic reactions.
Very rare (<1/10,000)
Anaphylaxis (dangerous allergic reaction rapid in onset), angioedema (local swelling of the skin). Hypersensitivity reaction (treatment should be stopped).
Hepatobiliary system disorders
Uncommon 01/1,000 to <1/100)
Bile duct disorders
Rare 01/10,000 to <1/1,000)
Hepatic toxicity, hepatic impairment that may lead to hepatic failure, increased activity of liver enzymes, liver necrosis, jaundice.
Very rare (<1/10,000)
Acute pancreatitis.
Psychiatric disorders:
Rare 01/10,000 to <1/1,000)
Sleep disorders, depression, confusion, hallucinations.
Not known (cannot be estimated from the available data)
Euphoria (in case of high doses).
Injury, poisoning and procedural complications
Rare 01/10,000 to <1/1,000)
Overdose and poisoning.
In some cases necrolysis (tissue detachment caused by degeneration), Stevens-Johnson’s syndrome, Erythema multiforme, laryngeal swelling, anaemia, hepatic changes and hepatitis, renal changes (severe renal impairment, renal inflammation, blood in urine, urinary retention), gastrointestinal adverse reactions and dizziness have been reported.
Signs of treatment discontinuation - sudden treatment discontinuation may induce withdrawal symptoms, which are tremor, insomnia, nausea, vomiting, sweating and increase in heart rate, increase in breathing rate and blood pressure elevation.
NOTE - tolerance to the drug reduces fast after treatment cessation, therefore a big dose administered before treatment cessation may have a later toxic effect.

Reporting of side effects

If you develop 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 www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Co-codamol

Keep this medicine out of the sight and reach of children.
Store below 25°C, in the original package, protected from moisture and light.
Do not use this medicine after the expiry date which is stated on the carton after {date DD.MM.YYYY}. The expiry date refers to the last day of that month.
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 Co-codamol contains:

-   The active substances are paracetamol and codeine phosphate hemihydrate. One tablet contains 500 mg of paracetamol and 8 mg of codeine phosphate hemihydrate.
-   The excipients are: colloidal silicon dioxide, corn starch, stearic acid.

What Co-codamol looks like and contents of the pack

Tablet is flat, round, white, with a scoring line.
20 tablets in blister package.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjördur Island
Manufacturer Actavis UK Limited Whiddon Valley, Barnstaple,
N Devon EX32 8 NS, United Kingdom
For any information about this medicine please contact the local representative of the Marketing Authorisation Holder:
Teva Estonian Branch
UAB Sicor Biotech Estonian Branch
Hallivanamehe 4
11317 Tallinn
Tel: +372 6610 801

This leaflet was last revised in September 2017






  Instruction, annotation source for medicine: State Agency of Medicines, Estonia





• Medicaments images are for illustrative purposes only and may differ from the actual product.


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