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ZERIDAME SR is a brand name for Tramadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of moderate to severe pain.
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. For doses not realisable / practicable with this medicinal product, other strengths of this medicinal product are available.
Unless otherwise prescribed, Zeridame SR Prolonged Release Tablets should be given as follows: Adults and adolescents older than 12 years: The usual initial dose is 100mg, twice daily, in the morning and evening. Dependent upon the needs of the patient, subsequent doses may be administered earlier than 12 hours, but must not be administered earlier than 8 hours after the previous dose.
Under no circumstances should more than two doses be taken in any one 24 hour period. If the painkilling is insufficient, the dose may be increased to: 150mg, twice daily or 200mg, twice daily. The smallest effective analgesic dose should always be used.
Daily doses of 400 mg of active substance must not be exceeded, unless exceptional medical reasons require so. Under no circumstances should Zeridame SR be used for longer than absolutely necessary. If long-term pain treatment with tramadol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether, and to what extent, further treatment is necessary.
Paediatric population Zeridame SR is not suitable for children under the age of 12 years. Geriatric patients A dose adjustment is not usually necessary in patients, up to 75 years without clinically manifest hepatic or renal insufficiency.
In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements. Renal insufficiency/dialysis and hepatic impairment In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed.
In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements. Method of administration Zeridame SR Prolonged Release Tablets should be swallowed completely, without breaking or chewing, independent of meals, with sufficient liquid.
Treatment goals and discontinuation Before initiating treatment with Zeridame SR, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
Undesirable effects reported are listed according to the following frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis. Nervous system disorders Very common: dizziness. Common: headache, drowsiness. Rare: changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle contractions, and syncope.
Not known:
Serotonin syndrome. 5) respiratory depression may occur. 5). Psychiatric disorders Rare: hallucinations, confusion, anxiety, sleep disturbances and nightmares. Psychic side-effects may vary individually in intensity and nature (depending on personality and duration of medication).
g. decision behaviour, perception disorders). 4), abuse and addiction may occur. Eye disorders Rare: blurred vision. Not known (cannot be estimated from the available data: mydriasis. Cardiac and vascular disorders Uncommon: effects on cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse).
These adverse effects may occur especially on intravenous administration and in patients who are physically stressed. Rare: bradycardia, increase in blood pressure. Respiratory, thoracic and mediastinal disorders Worsening of asthma has also been reported, though a causal relationship has not been established.
Not known:
Hiccups. Gastrointestinal disorders Very common: nausea. Common: vomiting, constipation, dry mouth.
Uncommon:
Retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea. Hepatobiliary disorders Very rare: an increase in liver enzyme values has been reported after use of tramadol. Skin and subcutaneous tissue disorders Common: sweating.
Zeridame SR should only be used following a strict benefit – risk evaluation and appropriate precautionary measures in the following cases: in patients dependent on opioids, patients suffering head injuries, shock, decreased level of consciousness of unknown origin, disturbances of the respiratory centre or function, or increased intracranial pressure, patients with moderate to severe impaired liver or kidney function.
Zeridame SR should not be used in combination with alcohol. In patients sensitive for opioids the medicine should be used cautiously. Concomitant use of Zeridame SR and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Zeridame SR concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Convulsions have been reported at therapeutic doses and the risk may be increased at doses exceeding the usual upper daily dose limit (400 mg).
The risk on convulsions may increase in patients taking tramadol and concomitant medication that can lower the seizure threshold. 5). Patients with a history of epilepsy or those susceptible to seizures should only be treated with tramadol if there are compelling reasons.
Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Zeridame SR. Repeated use of Zeridame SR can lead to opioid use disorder (OUD).
1 - acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic drugs. - patients receiving MAO – inhibitors, or within 2 weeks of their withdrawal. - patients with epilepsy not adequately controlled by treatment - opioid withdrawal treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tramadol in United Kingdom.
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During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4).
g. pruritus, rash, urticaria). Musculoskeletal and connective tissue disorders Rare: motorial weakness. Renal and urinary disorders Rare: micturition disorders (difficulty in passing urine and urinary retention). General disorders and administration site conditions Common: fatigue.
Uncommon: drug withdrawal syndrome. Drug dependence Repeated use of Zeridame SR can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient’s individual risk factors, dosage, and duration of opioid treatment.
Physical Dependence Dependence, abuse, addiction, and withdrawal reactions may occur. Symptoms which occur on withdrawal, mainly identical to withdrawal symptoms with opioids, may be: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastro intestinal symptoms.
Very rare: atypical withdrawal symptoms have been reported: panic attack, severe anxiety, hallucinations, paraesthesia, tinnitus, and other unusual central nervous system symptoms. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Zeridame SR may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2).
Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines).
For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with tramadol hydrochloride.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Tramadol is not a suitable substitute in opioid dependent patients. The product does not suppress morphine withdrawal symptoms although it is an opioid agonist. Fatal cases of unintended overdose are reported to be related with the use of other psycho-active medicines or substances including alcohol.
Tramadol should be prescribed with care in alcoholics and users of other psycho-active drugs. After long term treatment (> 3 months) of analgesics with use every second day or more frequently, headache may develop or aggravate. Cases of medication overuse headache (MOH) have been reported following not registered use of tramadol in the treatment of tension or cluster headache or migraine.
Headache caused by overuse of analgesics should not be treated by increasing the dose. In such cases the use of analgesics should be discontinued in consultation with a doctor. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Adrenal insufficiency Opioid analgesics may occasionally cause reversible adrenal insufficiency requiring monitoring and glucocorticoid replacement therapy.
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