SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Oxycare Tablets 250 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:

Oxytetracyline dihydrate 250 mg

Excipients:

Qualitative composition of excipients and other constituents	Quantitative composition if that information is essential for proper administration of the veterinary medicinal product
Quinoline Yellow (E104)	0.762 mg
Riboflavin (E101)	0.180 mg
Sunset Yellow (E110)	0.010 mg
Ferric Oxide yellow (E172)	0.008 mg
Cellulose microcrystalline
Lactose monohydrate
Sodium Starch glycollate Type A
Magnesium stearate
Silica,colloidal hydrated
Purified Water
Hypromellose (HPMC) 6
Talc
Titanium dioxide
Hydroxypropylcellulose
Polyethylene glycol (PEG) 3350

Yellow, round, convex tablets with a cross-snap-tab on one side.

3. CLINICAL INFORMATION

3.1 Target species

Dogs.

3.2 Indications for use for each target species

For the treatment of dogs with bacterial infections sensitive to tetracycline therapy only. Soft tissue infections caused by Staphylococcus aureus or Streptococcus spp. have been shown to be highly sensitive. Respiratory infections caused by Bordetella bronchiseptica are also commonly sensitive.

3.3 Contraindications

Do not use in cases of hypersensitivity to the active substance, to any tetracycline, or to any of the excipients.

3.4 Special warnings

Not applicable.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Oxytetracycline is deposited in growing teeth and bones and may cause yellow discolouration. It also crosses the placenta. For this reason, it is not recommended in late pregnancy or in young animals. Caution must be taken in treating animals with renal or hepatic dysfunction; in such cases, it may be necessary to reduce dosage levels.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to oxytetracycline should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, flush mouth with plenty of water, seek medical advice and show the label to the physician.

In case of eye contact, flush thoroughly with clean, running water. If irritation persists, seek medical attention. Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Dogs:

Undetermined frequency (cannot be estimated from the available data)

Small intestinal bacterial overgrowth1

¹ With prolonged use of antibiotics of all types, of non-susceptible organisms to that antibiotic. Where it occurs, therapy should be discontinued and appropriate control of the organisms substituted.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Pregnancy:

Oxytetracycline crosses the placenta. Do not use in late pregnancy.

3.8 Interaction with other medicinal products and other forms of interaction

The veterinary medicinal product must not be given concurrently with milk or antacids.

3.9 Administration routes and dosage

Oral use.

An initial dose of 50 mg/kg bodyweight should be given, followed by subsequent doses of 25 mg/kg every 12 hours for 5 days. To be taken by mouth at least one hour before or two hours after feeding.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Gastric lavage may be beneficial in the first hours after ingestion, and milk will reduce absorption. Most common signs of overdose would be vomiting, anorexia and/or diarrhoea, in which case fluid and electrolytes should be administered.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QJ01AA06.

4.2 Pharmacodynamics

Antibiotic of the tetracycline group, with a broad spectrum of activity against Mycoplasma, Chlamydia and Rickettsia and a range of Gram-positive and Gramnegative bacteria. (Little activity against E. coli, Salmonella, Proteus and Pseudomonads.) Tetracyclines are bacteriostatic; bacterial sensitivity testing is advisable to preclude resistance in the target infecting bacteria.

4.3 Pharmacokinetics

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Aluminium, magnesium and calcium interfere with absorption of oxytetracycline; it must not be given concurrently with milk or antacids.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

5.3 Special precautions for storage

Do not store above 25 °C.

Protect from light.

Return any ¼ tablet to the pot and use within 48 hours.

5.4 Nature and composition of immediate packaging

A white, polypropylene tub with a low-density polyethylene packing with a white, low-density polyethylene cap (push fit), containing 1000 tablets.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Ecuphar NV

7. MARKETING AUTHORISATION NUMBER

Vm 32742/4032

8. DATE OF FIRST AUTHORISATION

22 June 1992

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall

Approved: 23 July 2026