INN monograph
Diclofenac sodium / Paracetamol
Non-opioid analgesic / antipyretic · POM
Source-linked · Updated 03 Aug 2026 · Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Non-opioid analgesic / antipyretic)
Kenya market
Wholesale / list prices where loaded
Risk first
Contraindications
- [Diclofenac] Active peptic ulcer / GI bleeding.
- Severe heart failure.
- NSAID-exacerbated respiratory disease (aspirin-sensitive asthma) for non-selective agents.
- Third trimester pregnancy (ductus arteriosus, oligohydramnios — class warning).
- Severe renal impairment for many agents.
- Hypersensitivity to NSAIDs. [Paracetamol] Severe active hepatic disease / acute liver failure.
- Hypersensitivity.
- Chronic heavy alcohol use — use reduced maximum daily dose or avoid.
Precautions
- Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
- Symptoms may include: hives asthma (wheezing) skin reddening blisters facial swelling shock rash If an allergic reaction occurs, stop use and seek medical help right away.
- Liver warning: This product contains diclofenac.
- Liver damage may occur if you apply more or for a longer time than directed when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
- The chance is small but higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.
- These can be fatal.
- The risk is higher if you use more than directed or for longer than directed.
- Do not use if you have ever had an allergic reaction to any other pain reliever or to a fever reducer for strains, sprains, bruises or sports injuries.
- This product has not been shown to work for these types of injuries. right before or after heart surgery on more than 2 body areas at the same time in the eyes, nose or mouth Ask a doctor before us if you have problems or serious side effects from taking pain relievers or fever reducers stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke you are taking a diuretic you are under age 18 years.
- It is not known if this drug works or is safe in children under age 18 years.
- Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other drug When using this product avoid contact with eyes, nose, or mouth if eye contact occurs, rinse thoroughly with water Stop use and ask a doctor if pain gets worse or lasts more than 21 days redness or swelling is present in the painful area fever occurs skin irritation occurs any new symptoms appear.
- These could be signs of a serious condition. you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain trouble breathing leg swelling weakness in one part or side of body slurred speech If pregnant or breast-feeding, ask a health professional before use.
Point of care
Dosing
Adult
Directions Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams) For each lower body area (foot, ankle or knee) –Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions: use only as directed do not use more than directed or for longer than directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in same area as any other product do not apply with external heat such as heating pad do not apply a bandage over the treated area store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.
Paediatric
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Renal
Generally safe; prolonged high dose rare associations — prefer careful use in advanced CKD.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Hepatic
PRIMARY toxicity organ in overdose; therapeutic doses usually safe if daily limits respected.
Safety
Drug interactions
- Fixed-dose/multi-ingredient product.
- Clinical details partially inherited from component monographs: Diclofenac, Paracetamol.
- Confirm combination SmPC for exact dosing.
Safety
Adverse effects
- [Diclofenac] [From component Diclofenac] GIT disturbances, GIT ulceration, headache, dizziness, vertigo, tinnitus, taste alteration, blood dyscrasia, renal, hepatic disorders. [Paracetamol] Rare at therapeutic doses.
- Serious: acute liver failure in overdose, rare severe skin reactions (SJS/TEN/AGEP).
Use
Indications
- Uses for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain
- it is not for immediate relief.
- If no pain relief in 7 days, stop use.
Pharmacology
Mode of action
It acetylates prostaglandin endoperoxide synthase and irreversibly inhibits its cyclo-oxygenase [COX] activity.
Full mechanism text
It acetylates prostaglandin endoperoxide synthase and irreversibly inhibits its cyclo-oxygenase [COX] activity. This enzyme catalyzes the conversion of arachidonic acid to PGH2. It has two isoforms: COX-1 and COX-2. Acetylation of platelet cyclo-oxygenase prevents the synthesis of thromboxane A2 [a potent vasoconstrictor and inducer of platelet aggregation].
ADME
Pharmacokinetics & PD
| Onset | 30–60 minutes oral |
|---|---|
| Duration | 4–6 hours |
| Route | ORAL / RECTAL / IV |
| Metabolism | (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. |
| Half-life | ~2–3 h; prolonged in liver disease/overdose. |
Full PK/PD text
Rapid oral absorption. Hepatic metabolism (glucuronidation/sulfation); toxic NAPQI pathway via CYP2E1 when pathways saturated or glutathione depleted. Half-life ~2–3 h; prolonged in liver disease/overdose.
Kenya
Brands & prices
| Brand | Company | Pack | KES |
|---|---|---|---|
| No brands linked yet. | |||
Special populations
Pregnancy & lactation
Pregnancy
[Diclofenac] [Diclofenac] Avoid in third trimester. Earlier pregnancy: use only if needed; prefer paracetamol first-line. [Methyl Salicylate] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [Linseed Oil] Use only if potential benefit justifies potential risk; prefer agents with better reproductive data when alternatives exist. [Paracetamol] Analgesic/antipyretic of choice in pregnancy when needed; use lowest effective dose/shortest duration.
Lactation
[Diclofenac] [Diclofenac] Short-course ibuprofen generally acceptable; avoid chronic high-dose/long half-life agents when possible. [Methyl Salicylate] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data. [Linseed Oil] Assess infant risk vs benefit of maternal therapy; prefer agents with lactation data.
Diet
Food & alcohol
- Food
- Food
Trust
Sources & disclaimer
Source: Local active-ingredient clinical extract; FDA drug label via OpenFDA/DailyMed; Component monographs (multi-source pipeline); Professional class pharmacology (Non-opioid analgesic / antipyretic)
Clinical review date not recorded.
Decision support only — not a substitute for clinical judgment, product SmPC, or Kenya STG/EML.