SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cephacare Flavour 500 mg Tablets for Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:

500 mg cefalexin as cefalexin monohydrate.

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablets

Beige, flat tablets with a break mark on one side.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

Treatment of infections of the respiratory tract, gastro-intestinal tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.

4.3 Contraindications

Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the -lactam group or to any of the excipients.

Do not use in rabbits, gerbils, guinea pigs and hamsters.

4.4 Special warnings for each target species

None

(i) Special precautions for use in animals

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with penicillins, due to the potential for cross resistance.

In the case of an allergic reaction, treatment should be withdrawn.

As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In cases of known renal insufficiency the dose should be reduced, antimicrobials known to be nephrotoxic should not be administered concurrently and the product should be used only according to a risk/benefit assessment by the responsible veterinarian.

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

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross-reactions to cephalosporin and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised or if you have been advised not to be in contact with such substances.

Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Vomiting has been observed occasionally in dogs when given products containing cefalexin.

4.7 Use during pregnancy, lactation or lay

The safety of the product has not been demonstrated in studies in pregnant or lactating dogs. Use only in accordance with a risk/benefit assessment by the responsible veterinarian.

4.8 Interaction with other medicinal products and other forms of interaction

See section 4.5i Special precautions for use in animals.

The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (macrolides, sulphonamides and tetracyclines).

Nephrotoxicity can be increased when 1^stgeneration cephalosporins are combined with polypeptide antibiotics, aminoglycosides and some diuretics (furosemide).

Concomitant use with such active substances should be avoided.

4.9 Amounts to be administered and administration route

For oral administration. A dose of 15 mg/kg twice daily is recommended, to be doubled where appropriate.

Cephacare flavour 500 mg tablets have a break mark on one side. To enable more accurate dosing, half tablets may be used as necessary.

Treatment for five days is recommended. Any increase in dose or duration of use should be according to a risk/benefit assessment by the prescribing veterinarian (e.g. in cases of chronic pyoderma).

Tablets may be added to food if necessary.

To avoid underdosing, the bodyweight should be accurately determined.

The use of cefalexin tablets of lower strengths is advised for dogs with lower bodyweights.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The administration of cefalexin has been shown to produce no serious side-effects at many times the recommended dose rate.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group:

Antibacterials for systemic use, other beta-lactam antibacterials, first-generation cephalosporins.
ATCvet code: QJ01DB01.

5.1 Pharmacodynamic properties

Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cephalosporin group which acts by interference with bacterial cell wall formation.

Cefalexin is active against a wide range of Gram-positive and Gram-negative bacteria. The following micro-organisms have been shown to be sensitive to cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli, Micrococcus spp, Moraxella spp.

Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus that are insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin) because of production of penicillinase.

Cefalexin is also active against the majority of ampicillin-resistant E.coli.

5.2 Pharmacokinetic particulars

Following oral administration, cefalexin is rapidly and almost completely absorbed. Peak plasma concentrations in the dog (C_max= 17.49 μg/ml) are achieved within approximately 1.5 hours (T_max= 1.55). Cefalexin is excreted in the urine in high concentrations and has an elimination half life (T_1/2) of approximately 2.5–3 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Potato starch

Magnesium stearate

Beef flavour

6.2 Incompatibilities

Not applicable

6.3 Shelf life

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

Return any ½ tablet to the blister pack and use within 24 hours.

6.4 Special precautions for storage

Do not store above 25C.

Store in a dry place.

Keep the blister in the outer carton.

6.5 Nature and composition of immediate packaging

Cephacare flavour 500 mg tablets are supplied in PVC/aluminium foil blister packs each containing 10 tablets, in cardboard boxes containing 100 or 250 tablets.

Not all pack sizes may be marketed.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Animalcare Ltd.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

8. MARKETING AUTHORISATION NUMBER

Vm: 10347/4027

9. DATE OF FIRST AUTHORISATION

Date: 19 December 2008

10. DATE OF REVISION OF THE TEXT

Date: January 2014

PROHIBITION OF SALE, SUPPLY AND/OR USE

LABELLING AND PACKAGE LEAFLET

A. LABELLING

PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cephacare flavour 500 mg tablets for dogs.

Cefalexin as cefalexin monohydrate.

2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each tablet contains 500 mg cefalexin as cefalexin monohydrate.

Beef flavoured, beige, flat tablets with a break mark on one side.

3. PHARMACEUTICAL FORM

Tablet

4. PACKAGE SIZE

100 tablets

250 tablets

5. TARGET SPECIES

Dogs

6. INDICATION(S)

7. METHOD AND ROUTE(S) OF ADMINISTRATION

For oral administration.

A dose of 15 mg/kg twice daily is recommended, to be doubled where appropriate.

To enable more accurate dosing, half tablets may be used as necessary.

Read the package leaflet before use.

8. WITHDRAWAL PERIOD

Not applicable.

9. SPECIAL WARNING(S), IF NECESSARY

See package leaflet for user warnings and disposal advice. Penicillins and cephalosporins may occasionally cause severe allergic reactions.

10. EXPIRY DATE

EXP: DD/MM/YY

Return any ½ tablet to the blister pack and use within 24 hours.

11. SPECIAL STORAGE CONDITIONS

Do not store above 25C.

Keep the blister in the outer carton.

Store in a dry place.

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

See package leaflet for user warnings and disposal advice.

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only - to be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the sight and reach of children

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Animalcare Ltd.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

16. MARKETING AUTHORISATION NUMBER(S)

17. MANUFACTURER’S BATCH NUMBER

BN:

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

Blister

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cephacare flavour 500 mg tablets for dogs.

500 mg cefalexin

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Animalcare Ltd.

3. EXPIRY DATE

EXP: DD/MM/YY

4. BATCH NUMBER

BN:

5. THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

B. PACKAGE LEAFLET

PACKAGE LEAFLET

Cephacare flavour 500 mg tablets for dogs

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Animalcare Ltd.

10 Great North Way

York Business Park

Nether Poppleton

York

YO26 6RB

UK

Manufacturers responsible for batch release:

Lelypharma B.V.

Zuiveringweg 42

8243 PZ

Lelystad

The Netherlands

Produlab Pharma B.V.

Forellenweg 16

4941 SJ

Raamsdonksveer

The Netherlands

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cephacare flavour 500 mg tablets for dogs.

Cefalexin as cefalexin monohydrate.

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each tablet contains:

Active substance:

500 mg cefalexin as cefalexin monohydrate

Beef flavoured, beige, flat tablets with a break mark on one side.

4. INDICATIONS

Treatment of infections of the respiratory tract, gastrointestinal tract, urogenital tract, the skin and localised infections in soft tissue caused by bacteria sensitive to cefalexin.

5. CONTRAINDICATIONS

Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the -lactam group or to any of the excipients.

Do not use in rabbits, gerbils, guinea pigs and hamsters.

6. ADVERSE REACTIONS

Vomiting has been observed occasionally in dogs when given products containing cefalexin.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For oral administration. A dose of 15 mg/kg twice daily is recommended, to be doubled where appropriate.

9. ADVICE ON CORRECT ADMINISTRATION

Cephacare flavour 500 mg tablets have a break mark on one side. To enable more accurate dosing, half tablets may be used as necessary.

Treatment for 5 days is recommended. Any increase in dose or duration of use should be according to a risk/benefit assessment by the prescribing veterinarian (e.g. in cases of chronic pyoderma).

Tablets may be added to food if necessary.

To avoid underdosing, the bodyweight should be accurately determined.

The use of cefalexin tablets of lower strengths is advised for dogs with lower bodyweights.

10. WITHDRAWAL PERIOD

Not applicable

11. SPECIAL STORAGE PRECAUTIONS

Return any ½ tablet to the blister pack and use within 24 hours.

Keep the blister pack in the outer carton.

Keep out of the sight and reach of children.

Do not store above 25C.

Store in a dry place.

Do not use this veterinary medicinal product after the expiry date which is printed on the blister and carton after “Exp”. The expiry date refers to the last day of the month.

12. SPECIAL WARNINGS

For animal treatment only

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to cefalexin and may decrease the effectiveness of treatment with penicillins, due to the potential for cross resistance.

In the case of an allergic reaction, treatment should be withdrawn.

The administration of cefalexin has been shown to produce no serious side-effects at many times the recommended dose rate.

As with other antibiotics which are excreted mainly by the kidneys, unnecessary accumulation may occur in the body when renal function is impaired. In cases of known renal insufficiency the dose should be reduced, antimicrobials known to be nephrotoxic should not be administered concurrently and the product should be used only according to a risk/benefit assessment by the responsible veterinarian.

The bactericidal activity of cephalosporins is reduced by concomitant administration of bacteriostatic acting compounds (macrolides, sulphonamides and tetracyclines).

Nephrotoxicity can be increased when 1^stgeneration cephalosporins are combined with polypeptide antibiotics, aminoglycosides and some diuretics (furosemide).

Concomitant use with such active substances should be avoided.

The safety of the product has not been demonstrated in studies in pregnant or lactating dogs. Use only in accordance with a risk/benefit assessment by the responsible veterinarian.

User warnings

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

September 2009

15. OTHER INFORMATION

Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cephalosporin group which acts by interference with bacterial cell wall formation.

Cefalexin is active against a wide range of Gram-positive and Gram-negative bacteria. The following micro-organisms have been shown to be sensitive to cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia coli, Micrococcus spp, Moraxella spp.

Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus that are insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin) because of production of penicillinase.

Cefalexin is also active against the majority of ampicillin-resistant E.coli.

Following oral administration, cefalexin is rapidly and almost completely absorbed. Peak plasma concentrations in the dog (C_max= 17.49 μg/ml) are achieved within approximately 1.5 hours (T_max= 1.55). Cefalexin is excreted in the urine in high concentrations and has an elimination half life (T_1/2) of approximately 2.5–3 hours.

Cephacare flavour 500 mg tablets are supplied in packs of 100 and 250 tablets.

Not all pack sizes may be marketed.

Prescription Only Medicine

20 February 2014