Leaflet DOLTEN 50mg film-coated tablets

Product code:
W69554014
Quantity:
100
Indicated for:
moderate to severe pain
Route of administration:
oral
Substance:
tapentadol (opioid analgesic)
ATC
N02AX06 — Nervous system | Opioids | Other opioids

Precautions:

Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Dependence / abuse

This medicine may cause dependence or be misused.

Respiratory depression

May slow breathing, especially with alcohol or sedatives.

Avoid alcohol

Avoid alcohol during treatment.

Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Elderly warning

Older people may have an increased risk of side effects.

Seizure risk

This medicine may increase the risk of seizures.

Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

Tapentadol is an opioid analgesic used for the treatment of moderate to severe pain. It works by activating opioid receptors and inhibiting norepinephrine reuptake, providing effective pain relief.

The medication is taken orally, as directed by a doctor, usually at regular intervals. It is important for patients to follow the prescribed dosage to avoid the risk of dependence or overdose.

Patients should be aware of potential side effects, such as drowsiness, dizziness, or nausea. It is important to inform the doctor of any unusual symptoms.

Common side effects include drowsiness, dizziness, nausea, and constipation. In rare cases, severe reactions such as respiratory depression or allergic reactions may occur. Patients should be informed of these risks before starting treatment.

General data about DOLTEN 50mg

Substance:
tapentadol
Date of latest medicines list:
01-12-2023
Product code:
W69554014
Concentration:
50mg
Pharmaceutical form:
film-coated tablets
Quantity:
100
Product type:
Generic medicine
Prescription status:
TAB2 — Medicines dispensed with a special medical prescription for narcotic substances, yellow in color.

Marketing authorisation

Manufacturer:
MEDOCHEMIE LTD. - CIPRU
Holder:
MEDOCHEMIE LTD. - CIPRU
Number:
14986/2023/14
Shelf life:
2 years

Concentrations available for tapentadol

  • 100mg
  • 150mg
  • 200mg
  • 20mg/ml
  • 250mg
  • 25mg
  • 4mg/ml
  • 50mg
  • 75mg