Macrobid capsules macrodantin capsules

Prescribing Information

Tramadol 100 mg/ml oral drops, solution.
Presentation: Tramadol drops are supplied as a 10 ml amber glass bottle
with 1ml containing 100 mg of tramadol hydrochloride.
Excipients: 1 ml contains 200 mg sucrose (see section 4.4). For a full list
of recipients, see section 6.1.
Indications: Treatment of moderate to severe pain.
Dosage and administration: For oral administration.
Should be diluted with water before administration, independent of meals.
It is recommended to start with the lowest analgesically effective dose. Daily
doses of 400 mg should not be exceeded, except in special clinical
circumstances. Adults and adolescents above the age of 12 years: usual
daily dose is 50 to 100 mg (20 to 40 drops), 3 to 4 times a day. Children
from 12 to 14 years, the lowest dose should be used. For acute pain, an
initial dose of 100 mg is usually necessary. For chronic pain, an initial dose of
50 mg is advised to be slowly increased to the final recommended dose every
2 to 3 days in order to reduce the incidence of adverse events. Below the
age of 12 years tramadol drops are not suitable for children. Geriatric
patients: No dose adjustment necessary in elderly patients up to 75 years
without clinically manifest hepatic or renal insufficiency. Dosage interval
should be extended according to the patients requirements in patients over
75 years as they may have prolonged elimination. Tramadol drops are not
recommended in of severe renal and/or severe hepatic insufficiency.
Contraindications: Tramadol drops are contraindicated in hypersensitivity
to tramadol or any of the excipients, in acute intoxication with alcohol,
hypnotics, analgesics, opioids or other psychotropic medicinal products, in
patients who are receiving MAO inhibitors or who have taken them within the
last 14 days, in patients with epilepsy not adequately controlled by
treatment, and for use in narcotic withdrawal treatment.
Warnings and Special Precautions: Caution is recommended in
opioid-dependent patients, patients with head injury, shock, reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure and in patients sensitive to opiates. The possibility of respiratory depression cannot be excluded if concomitantly administered with CNS depressant drugs or if the recommended dosage is significantly exceeded. Convulsions may occur even at the recommended doses risk in patients taking products that lowers the seizure threshold. The risk is increased if the upper daily dose limit (400 mg) is exceeded. Use in patients with epilepsy or those susceptible to seizures only if there are compelling circumstances. Tolerance, psychic and physical dependence may develop with long-term use. Short treatment periods are advised in patients with a tendency to drug abuse or dependence. Tramadol cannot suppress morphine withdrawal symptoms and is not a suitable substitute in opioid- dependent patients. Not recommended in patients with fructose intolerance,
glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Contains sucrose.
Pregnancy and lactation: Tramadol crosses the placenta and is
contraindicated in pregnancy due to inadequate safety evidence in human pregnancy. Very high dose animal studies revealed effects on organ development, ossification and neonatal mortality but no teratogenicity. No effect on uterine contractility when administered before or during birth may induce insignificant changes in neonatal respiratory rate. Chronic use during pregnancy may lead to neonatal withdrawal symptoms. Small amounts are secreted into breast milk therefore not recommended during breast-feeding.
Interactions: Concurrent use ,with MAO inhibitors, CNS depressants
including alcohol, carbamazepine (enzyme inducer), buprenorphine, nalbuphine, pentazocine, selective serotonin re-uptake inhibitors, tricyclic antidepressants, anti-psychotics and other seizure threshold-lowering medicinal products , coumarin derivatives (e.g. warfarin) and CYP3A4 inhibitors, such as ketoconazole and erythromycin. The pre- or postoperative
ondansetron may increase the requirement of tramadol in patients with
postoperative pain
Undesirable effects: The most commonly reported adverse reactions are
nausea and dizziness, headache, drowsiness, somnolence, constipation, dry mouth, vomiting, dyspepsia, abdominal pain, sweating, menopausal symptoms, fatigue, asthenia, and malaise occur commonly. Less commonly seen are toxic epidermal necrolysis (TEN) and Stevens-Johnson-syndrome (SJS), and cross reactivity with non steroidal anti-inflammatory drugs. Palpitation, tachycardia, postural hypotension or cardiovascular collapse may occur on intravenous administration or in physically stressed patients bradycardia and hypertension are rare. Anorexia, retching, gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea, dermal reactions (e.g. pruritus, rash, urticaria) also occur less commonly. Rare side effects include: changes in appetite, increased liver enzymes, blurred vision, paraesthesia, tremor, respiratory depression, dyspnoea, worsening of asthma epileptiform convulsions, involuntary muscle contractions, muscle weakness, abnormal coordination, syncope, hypertonia and dysgeusia, micturition disorders , menstrual disorders, weight loss, allergic reactions, anaphylaxis, withdrawal reactions like agitation, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms may occur, psychic reactions like hallucinations, confusion, sleep disturbance, anxiety and nightmares occur rarely dependence, suicidal ideation, drug abuse addiction, panic attacks, severe anxiety, hallucinations,
paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions,
depersonalization, derealization, paranoia have also been seen with tramadol
discontinuation. Overdose: Symptoms may include: miosis, vomiting,
cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest. The antidote for respiratory depression is naloxone. If convulsions occur, administer intravenous diazepam. Decontamination with activated charcoal or gastric lavage is only
recommended within 2 hours after oral intoxication

Please refer to the Summary of Product Characteristics for detailed
information.

Legal Category: POM.
Basic NHS Price: £3.50 per pack of 1 10ml bottle
Marketing Authorisation number: PL 12762/0453
Marketing Authorisation Holder: Amdipharm Mercury Company
Limited, NLA Tower, Croydon, CR0 0XT, Trading as Mercury Pharmaceuticals.
Date of last review: June 2013
Adverse events should be reported to the local regulatory authority.
Reporting forms and information can be found at
. Adverse events should also be
reported to Amdipharm Mercury Medical Information at 08700
70 30 33 or via e-

Source: http://www.data4nhs.com/ExEmsg/dlit/1309134/PI-Tramadol.pdf